What is the recommended dosage of Abilify for schizophrenia. How should Abilify be administered for bipolar disorder. What is the proper dosing for major depressive disorder. How is Abilify used in treating autism-related irritability. What are the dosage guidelines for Tourette’s disorder.

Abilify Dosage for Schizophrenia: Adult and Adolescent Guidelines

Abilify, also known by its generic name aripiprazole, is a widely prescribed atypical antipsychotic medication. For adults with schizophrenia, the recommended starting and target dose is typically 10 to 15 mg per day. This dose is administered once daily, regardless of meals. While the effective dose range spans from 10 to 30 mg daily, it’s important to note that doses exceeding 10 or 15 mg did not demonstrate superior efficacy.

How soon can dosage increases be considered? Physicians generally wait at least two weeks before adjusting the dose, allowing time for the medication to reach steady-state levels in the body. This cautious approach helps minimize side effects while optimizing therapeutic benefits.

Maintenance Treatment for Schizophrenia

For long-term management of schizophrenia, Abilify’s efficacy as a maintenance treatment has been established through clinical trials. Patients who had been stable on other antipsychotics for at least three months were switched to either Abilify 15 mg daily or a placebo. The study monitored these individuals for potential relapse, highlighting the importance of Abilify in maintaining symptom control.

How often should patients be reassessed during maintenance treatment? Regular reassessments are crucial to determine the ongoing need for maintenance therapy. These evaluations help ensure that the benefits of continued treatment outweigh any potential risks or side effects.

Adolescent Dosing for Schizophrenia

For adolescents aged 13 to 17 with schizophrenia, the recommended target dose of Abilify is 10 mg per day. The dosing strategy for this age group involves a gradual titration:

1. Starting dose: 2 mg daily
2. After 2 days: Increase to 5 mg daily
3. After 2 more days: Reach the target dose of 10 mg daily

Can the dose be increased beyond 10 mg for adolescents? While a 30 mg daily dose was studied, it did not show superior efficacy compared to the 10 mg dose. Therefore, increases should be carefully considered and implemented in 5 mg increments if necessary.

Bipolar I Disorder: Abilify Dosage for Manic and Mixed Episodes

Abilify plays a significant role in managing acute manic and mixed episodes associated with Bipolar I Disorder. The dosing recommendations vary depending on whether it’s used as monotherapy or as an adjunctive treatment with other mood stabilizers.

Adult Dosing for Bipolar I Disorder

For adults, the recommended starting dose differs based on the treatment approach:

• Monotherapy: 15 mg once daily
• Adjunctive therapy with lithium or valproate: 10 to 15 mg once daily

What is the target dose for Bipolar I Disorder in adults? The recommended target dose is 15 mg per day, whether used alone or in combination with lithium or valproate. In cases where clinical response is insufficient, the dose may be increased to 30 mg per day. However, it’s crucial to note that the safety of doses exceeding 30 mg daily has not been thoroughly evaluated in clinical trials.

Pediatric Dosing for Bipolar I Disorder

For pediatric patients aged 10 to 17 years, Abilify dosing follows a gradual titration schedule:

1. Starting dose: 2 mg per day
2. After 2 days: Increase to 5 mg per day
3. After 2 more days: Reach the target dose of 10 mg per day

This schedule applies to both monotherapy and adjunctive therapy with lithium or valproate.

How should dose increases be handled in pediatric patients? If needed, subsequent dose increases should be administered in 5 mg per day increments. As with adults, Abilify can be given without regard to meals in this population.

Adjunctive Treatment of Major Depressive Disorder with Abilify

Abilify has shown efficacy as an adjunctive treatment for adults with Major Depressive Disorder (MDD) who have had an inadequate response to antidepressant therapy alone. The dosing strategy for this indication requires careful titration and monitoring.

What is the recommended starting dose for adjunctive treatment in MDD? For patients already taking an antidepressant, the recommended starting dose of Abilify is 2 to 5 mg per day. The dosage can be adjusted within a range of 2 to 15 mg daily, based on clinical response and tolerability.

How should dose adjustments be made in MDD treatment? Dosage adjustments of up to 5 mg per day should occur gradually, with intervals of at least one week between increases. This cautious approach helps minimize side effects while optimizing therapeutic benefits.

Regular reassessments are crucial to determine the ongoing need for maintenance treatment in MDD. These evaluations help ensure that the benefits of continued adjunctive therapy with Abilify outweigh any potential risks or side effects.

Abilify for Irritability Associated with Autistic Disorder

Abilify has demonstrated effectiveness in managing irritability associated with autistic disorder in pediatric patients. The dosing recommendations for this indication are specifically tailored to children and adolescents aged 6 to 17 years.

Dosage Range and Titration Schedule

What is the recommended dosage range for autism-related irritability? The recommended dosage range for pediatric patients with irritability associated with autistic disorder is 5 to 15 mg per day. However, the initiation and titration of the dose follow a specific schedule:

1. Starting dose: 2 mg per day
2. Increase to 5 mg per day
3. Subsequent increases to 10 or 15 mg per day if needed

How should dose adjustments be implemented? Dose adjustments of up to 5 mg per day should occur gradually, with intervals of no less than one week between increases. This measured approach allows for careful monitoring of the patient’s response and minimizes the risk of adverse effects.

Ongoing Assessment and Maintenance

The treatment of irritability associated with autistic disorder requires ongoing evaluation to ensure its continued efficacy and safety. Patients should be periodically reassessed to determine the need for maintenance treatment. These regular check-ins allow healthcare providers to adjust the treatment plan as necessary, considering factors such as symptom improvement, tolerability, and overall quality of life.

Tourette’s Disorder: Abilify Dosage Guidelines for Pediatric Patients

Abilify has shown effectiveness in managing symptoms of Tourette’s Disorder in pediatric patients. The dosing recommendations for this condition are specific to children and adolescents aged 6 to 18 years.

Recommended Dosage Range

What is the recommended dosage range for Tourette’s Disorder? The recommended dosage range for Tourette’s Disorder is 5 to 20 mg per day. However, the initial dosing and subsequent adjustments depend on the patient’s weight and response to treatment.

Weight-Based Dosing Considerations

How does a patient’s weight affect the initial dosing of Abilify for Tourette’s Disorder? For patients weighing less than 50 kg:

1. Initial dose: 2 mg per day
2. Target dose: 5 mg per day after 2 days
3. Potential increase: Up to 10 mg per day for patients not achieving optimal symptom control

For patients weighing 50 kg or more, the dosing strategy may differ slightly, with potential for higher doses within the recommended range of 5 to 20 mg per day. As with other indications, dose adjustments should be made gradually and under close medical supervision.

Special Considerations for Abilify Dosing Across Indications

While specific dosing guidelines exist for each indication, there are several overarching considerations that apply to Abilify use across all conditions. These factors can significantly impact the medication’s efficacy and the patient’s overall experience with treatment.

Timing of Administration

Can Abilify be taken with or without food? One of the advantages of Abilify is its flexibility in terms of administration. For all indications discussed, Abilify can be taken with or without meals. This feature can enhance medication adherence, as patients are not bound to specific meal times for dosing.

Gradual Dose Adjustments

Why is gradual dose adjustment important with Abilify? Across all indications, a common theme is the importance of gradual dose adjustments. This approach allows for:

• Better tolerability and fewer side effects
• Opportunity to assess the patient’s response at each dose level
• Time for the patient’s body to adjust to the medication
• Ability to find the lowest effective dose for each individual

Regular Monitoring and Reassessment

How often should patients on Abilify be reassessed? Regular monitoring and reassessment are crucial components of Abilify treatment across all indications. The frequency of these evaluations may vary depending on the condition being treated, the patient’s response, and any co-existing medical conditions. Generally, more frequent assessments are recommended during the initial titration period and when dose adjustments are made.

Switching from Other Antipsychotics to Abilify

For patients transitioning from other antipsychotic medications to Abilify, there are important considerations to ensure a smooth and safe transition. While specific data on switching protocols are limited, general principles can guide this process.

Individualized Approach to Switching

How should the transition from other antipsychotics to Abilify be managed? The approach to switching should be individualized based on the patient’s clinical status, previous medication, and specific needs. Some patients may tolerate an immediate discontinuation of their previous antipsychotic, while others may require a more gradual transition.

For those requiring a gradual approach, a cross-titration method is often employed. This involves slowly decreasing the dose of the current antipsychotic while gradually introducing and increasing the dose of Abilify. The goal is to minimize the period of overlapping antipsychotic administration while ensuring continuous symptom control.

Monitoring During Transition

What should be monitored during the transition to Abilify? Close monitoring during the switching process is essential. Healthcare providers should watch for:

• Changes in symptom control
• Emergence of withdrawal symptoms from the previous medication
• Potential drug interactions
• New side effects or changes in existing side effects

Regular follow-ups and open communication between the patient and healthcare provider are crucial during this transition period to ensure a successful switch to Abilify.

Abilify Dosage Guide – Drugs.com

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Generic name: ARIPIPRAZOLE 2mg
Dosage form: tablet, oral solution, orally disintegrating tablet, injection
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Nov 30, 2022.

Schizophrenia

Adults

The recommended starting and target dose for ABILIFY is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see Clinical Studies (14.1)].

Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either ABILIFY 15 mg/day or placebo, and observed for relapse [see Clinical Studies (14.1)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Adolescents

The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals [see Clinical Studies (14.1)]. Patients should be periodically reassessed to determine the need for maintenance treatment.

Switching from Other Antipsychotics

There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.

Bipolar I Disorder

Acute Treatment of Manic and Mixed Episodes

Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. ABILIFY can be given without regard to meals. The recommended target dose of ABILIFY is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.

Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. ABILIFY can be given without regard to meals [see Clinical Studies (14.2)].

Adjunctive Treatment of Major Depressive Disorder

Adults

The recommended starting dose for ABILIFY as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week [see Clinical Studies (14.3)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Irritability Associated with Autistic Disorder

Pediatric Patients (6 to 17 years)

The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day.

Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week [see Clinical Studies (14.4)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Tourette’s Disorder

Pediatric Patients (6 to 18 years)

The recommended dosage range for Tourette’s Disorder is 5 to 20 mg/day.

For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than one week.

For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on Day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than one week [see Clinical Studies (14.5)].

Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)

Adults

The recommended dose in these patients is 9.75 mg. The recommended dosage range is 5.25 to 15 mg. No additional benefit was demonstrated for 15 mg compared to 9.75 mg. A lower dose of 5.25 mg may be considered when clinical factors warrant. If agitation warranting a second dose persists following the initial dose, cumulative doses up to a total of 30 mg/day may be given. However, the efficacy of repeated doses of ABILIFY injection in agitated patients has not been systematically evaluated in controlled clinical trials. The safety of total daily doses greater than 30 mg or injections given more frequently than every 2 hours have not been adequately evaluated in clinical trials [see Clinical Studies (14. 6)].

If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 to 30 mg/day should replace ABILIFY injection as soon as possible [see Dosage and Administration (2.1 and 2.2)].

Administration of ABILIFY Injection

To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 1. Discard any unused portion.

ABILIFY Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosage Adjustments for Cytochrome P450 Considerations

Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers (see Table 2). When the coadministered drug is withdrawn from the combination therapy, ABILIFY dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, ABILIFY dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response.

Table 2: Dose Adjustments for ABILIFY in Patients who are known CYP2D6 Poor Metabolizers and Patients Taking Concomitant CYP2D6 Inhibitors, 3A4 Inhibitors, and/or CYP3A4 Inducers

Factors	Dosage Adjustments for ABILIFY
Known CYP2D6 Poor Metabolizers	Administer half of usual dose
Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors (e. g., itraconazole, clarithromycin)	Administer a quarter of usual dose
Strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors (e.g., itraconazole, clarithromycin)	Administer half of usual dose
Strong CYP2D6 and CYP3A4 inhibitors	Administer a quarter of usual dose
Strong CYP3A4 inducers (e.g., carbamazepine, rifampin)	Double usual dose over 1 to 2 weeks

When adjunctive ABILIFY is administered to patients with major depressive disorder, ABILIFY should be administered without dosage adjustment as specified in Dosage and Administration (2.3).

Dosing of Oral Solution

The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see Clinical Pharmacology (12.3)].

Dosing of Orally Disintegrating Tablets

The dosing for ABILIFY Orally Disintegrating Tablets is the same as for the oral tablets [see Dosage and Administration (2. 1, 2.2, 2.3, and 2.4)].

Frequently asked questions

• Does Abilify cause gambling addiction?
• Why should you take aripiprazole in the morning?
• Does Abilify cause weight gain?
• Vraylar vs Abilify – How do they compare?
• What is the difference between Abilify and Abilify Maintena?
• How does Abilify MyCite work?

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Patient resources

• Drug Information
• Abilify (Aripiprazole Intramuscular) (Advanced Reading)
• Abilify (Aripiprazole Oral) (Advanced Reading)
• Abilify (Aripiprazole Injection)
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Aristada, Abilify Asimtufii, Aristada Initio, Abilify Discmelt

Professional resources

• Prescribing Information

Other formulations

• Abilify Maintena
• Abilify MyCite Maintenance Kit oral with sensor

Related treatment guides

• Bipolar Disorder
• Agitated State
• Autism
• Depression

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Forms, Strengths, How to Use, and More

Abilify (aripiprazole) is used to treat certain mental health conditions or mood disorders. It may be prescribed to adults and some children. The drug comes in oral tablet and injection forms, taken daily or monthly.

Abilify is used to treat these conditions:

• major depressive disorder in adults
• manic episodes and mixed episodes associated with bipolar I disorder in adults and some children, sometimes taken with another drug
• schizophrenia in adults and some children
• irritability associated with autism spectrum disorder in some children
• Tourette syndrome in some children

The active ingredient in Abilify is aripiprazole. (An active ingredient is what makes a drug work.) Abilify belongs to a group of drugs called atypical antipsychotics.

This article describes the dosages of Abilify, as well as its strengths and how to take it. Some forms discussed are called Abilify MyCite and Abilify Maintena. To learn more about Abilify overall, see this in-depth article.

Below are the usual doses of Abilify in adults.

Note: This chart highlights the basics of Abilify’s dosage in adults. Be sure to read on for more detail, including specific dosages for children.

What are the forms of Abilify?

Abilify comes in the following forms:

• oral tablet that you swallow (Abilify)
• oral tablet with an embedded sensor, which you swallow (Abilify MyCite)*
• powder for mixing with sterile water in a single-dose, prefilled dual-chamber syringe, which is injected into a muscle (Abilify Maintena)
• powder for mixing with sterile water in a single-dose vial, which is injected into a muscle (Abilify Maintena)

* A sensor is embedded in the tablet. You must wear an accompanying patch that records information from the sensor. The information is then sent to a smartphone.

What strengths does Abilify come in?

Abilify oral tablet and Abilify MyCite oral tablet come in the following strengths:

• 2 mg
• 5 mg
• 10 mg
• 15 mg
• 20 mg
• 30 mg

Abilify Maintena syringe and vial come in the following strengths:

• 300 mg
• 400 mg

What are the usual dosages of Abilify?

Your doctor will likely start by prescribing a low dosage and adjust it over time to reach the right amount for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The information below describes dosages of Abilify and Abilify MyCite that are commonly prescribed or recommended for adults. (You’ll find Abilify Maintena dosages in “What are the usual dosages of Abilify Maintena?” below.) But be sure to take the dosage your doctor prescribes for you. They’ll determine the best dosage to fit your needs.

Dosage for depression

Abilify is approved to treat major depressive disorder in adults. This condition is often called depression.

The usual starting dose of Abilify is 2 mg to 5 mg once per day. If your doctor increases your dosage, each week they will usually add up to 5 mg to your daily dose. The drugmaker recommends a dosage range of 2 to 15 mg once per day. The maximum dosage is 15 mg once per day.

Dosage for bipolar I disorder

Abilify is approved to treat manic episodes and mixed episodes associated with bipolar I disorder in adults. For this condition, Abilify is usually taken with another drug, either lithium or valproate.

The usual starting dosage of Abilify is 15 mg once per day. This is also the recommended maintenance dosage. (This is the dosage you’ll continue to take at the completion of your starting dosage.) The maximum dosage is 30 mg once per day.

Dosage for schizophrenia

Abilify is approved to treat schizophrenia in adults.

The usual starting dosage of Abilify is 10 mg to 15 mg once per day. This is also the recommended dosage range. If your doctor increases your dosage, they may wait 2 weeks to learn how the drug affects you. The maximum dosage is 30 mg once per day.

What are the usual dosages of Abilify Maintena?

Abilify Maintena is a long-acting form of Abilify prescribed only to adults, not children. It is given by a healthcare professional as an injection into your muscle.

People who are already taking Abilify tablets can receive Abilify Maintena. Likewise, people who are starting Abilify for the first time can receive Abilify Maintena. Continue reading to learn more about its usual injection dosage.

Dosage for bipolar I disorder

Abilify Maintena is approved to treat manic episodes and mixed episodes associated with bipolar I disorder in adults.

The usual dosage is 400 mg once per month. For 14 days after the first injection, you’ll usually take 10 mg to 20 mg of Abilify oral tablet as well. (This is to help keep a steady level of the drug in your body.) But you might already be taking a different oral antipsychotic drug. In this case, you’ll continue that drug for 14 days after your first Abilify injection.

If you have side effects with the Abilify 400-mg injection, your doctor may decrease your dosage to 300 mg once per month.

Dosage for schizophrenia

Abilify Maintena is approved to treat schizophrenia in adults.

The usual dosage is 400 mg once per month. For 14 days after the first injection, you’ll usually take 10 mg to 20 mg of Abilify oral tablet as well. (This is to help keep a steady level of the drug in your body.) But you might already be taking a different oral antipsychotic drug. In this case, you’ll continue that drug for 14 days after your first Abilify injection.

If you have side effects with the 400-mg injection, your doctor may decrease your dosage to 300 mg once per month.

What’s the dosage of Abilify for children?

The information below describes dosages of Abilify that are commonly prescribed or recommended for children. Be sure to give your child the dosage that your child’s doctor prescribes. They will determine the dosage that best fits your child’s needs.

Dosage for bipolar I disorder

Abilify is approved to treat manic episodes and mixed episodes associated with bipolar I disorder in children ages 10 to 17 years. For this condition, Abilify may be used alone or with another drug, either lithium or valproate.

Your child’s Abilify starting dosage will typically be increased in the first week. As such, the starting dosage schedule may be as follows:

• 2 mg once per day for the first 2 days
• 5 mg once per day for the next 2 days
• 10 mg once per day after that

The recommended maintenance dosage is 10 mg once per day. (The maintenance dosage is what your child will continue to take at the completion of the starting dosage.) The maximum dosage is 30 mg once per day.

Dosage for schizophrenia

Abilify is approved to treat schizophrenia in children ages 13 to 17 years.

Your child’s Abilify starting dosage will typically be increased in the first week. As such, the starting dosage schedule may be as follows:

• 2 mg once per day for the first 2 days
• 5 mg once per day for the next 2 days
• 10 mg once per day after that

The recommended maintenance dosage is 10 mg once per day. (The maintenance dosage is what your child will continue to take at the completion of the starting dosage.)

The doctor may decide to increase your child’s dosage to more than 10 mg once per day. If so, they will usually increase it by 5 mg at a time. During the first week of treatment, the first two dose increases will be every 2 days. Additional increases, if any, will occur after the child has completed at least 1 week at the previous dose. The recommended maximum dosage is 30 mg once per day.

Dosage for irritability associated with autism spectrum disorder

Abilify is approved to treat irritability associated with autism spectrum disorder in children ages 6 to 17 years.

Your child’s Abilify starting dosage will usually be 2 mg once per day. Then the doctor may increase it to a dosage of 5 mg once per day. After that, they may increase it to a dosage of 10 mg or 15 mg once per day. The maximum dosage is 15 mg once per day.

When your child’s doctor increases the dosage, it is best done slowly. The dose increase should not be more than 5 mg. During the first week of treatment, the first two dose increases will likely be every 2 days. Additional increases, if any, may occur after your child has completed at least 1 week at the previous dose.

Dosage for Tourette syndrome

Abilify is approved to treat Tourette syndrome in children ages 6 to 18 years. Your child’s dose will depend on their body weight. (For reference, 1 kilogram [kg] is about 2.2 pounds [lb].)

Children who weigh less than 50 kg (less than about 110 lb). Your child’s usual starting dosage will be as follows:

• 2 mg once per day for the first 2 days
• 5 mg once per day for the next 5 days
• 10 mg once per day after that

The maximum dosage is 10 mg once per day.

Children who weigh 50 kg or more (about 110 lb). Your child’s usual starting dosage will be as follows:

• 2 mg once per day for the first 2 days
• 5 mg once per day for the next 5 days
• 10 mg once per day after that

If your child’s doctor increases the dosage to more than 10 mg once per day, they may do so slowly. The increases will likely not occur more often than once per week and 5 mg at a time. The maximum dosage is 20 mg once per day.

Is Abilify used long term?

Yes, Abilify is usually prescribed as a long-term treatment. If you and your doctor determine that it’s safe and effective for your condition, you’ll likely take it long term.

Dosage adjustments

Some people have certain liver conditions that cause their body to break down Abilify more slowly. If you have a certain liver condition, your doctor may start by prescribing a lower dose. You can find out more about genetic testing for these conditions in this article.

Some drugs interact with Abilify. If you take one of these drugs, your doctor may adjust your Abilify dosage. Or they may adjust your dosage of the other drug. Examples of these drugs include:

• paroxetine
• clarithromycin
• carbamazepine
• clonazepam

Talk with your doctor about all the medications you take before starting Abilify. And let them know if you plan to start any new medications.

Below are answers to some commonly asked questions about Abilify’s dosage.

What is Abilify’s maximum dosage?

Abilify has maximum dosages for some conditions it’s approved to treat. The highest dose of Abilify that you’ll take daily depends on the condition you’re taking it to treat.

Below are maximum dosages of Abilify for several conditions:

• major depressive disorder in adults: 15 milligrams (mg) once per day
• manic episodes and mixed episodes associated with bipolar I disorder in adults and children: 30 mg once per day
• schizophrenia in adults and children: 30 mg once per day
• irritability associated with autism spectrum disorder in children: 15 mg once per day
• Tourette syndrome in children: 10 mg or 20 mg once per day depending on body weight

Talk with your doctor if you think your dosage of Abilify may need to be increased. Do not try to increase or change your dosage on your own.

Is there less risk of side effects from Abilify if I take a lower dose of the drug, such as 5 mg?

Yes, sometimes a lower dose of Abilify may lessen the risk of side effects.

Some people process the drug more slowly. An example is people who have certain liver conditions. In this case, a lower dose can lessen their risk of side effects.

Your doctor usually will prescribe the lowest starting dosage recommended for your condition. For treating some conditions, they may then increase your dosage slowly.

You and your doctor can discuss the risk of side effects and the benefits of treating your condition.

Abilify is sometimes prescribed off-label at different dosages. Off-label means a drug is prescribed for a condition it is not officially approved to treat. Expert medical opinion and ongoing research determine the dosages for off-label uses.

When Abilify is taken off-label, it’s usually prescribed at doses lower than what the drugmaker recommends. This is often called low dose Abilify.

Some very early research has used lower doses of Abilify. This research includes:

• a study in delayed sleep phase syndrome
• a study in obsessive-compulsive disorder
• a study in chronic fatigue syndrome*

Anxiety often accompanies other mental health conditions that Abilify treats. Some early research has studied Abilify for treating anxiety. It found that high dose or low dose Abilify may help for anxiety.

But in the treatment of certain conditions, side effects may include anxiety and agitation. These side effects may occur when treating schizophrenia with Abilify.

Each person responds to medications differently. With Abilify, it’s possible that your anxiety might lessen, get worse, or stay the same. Talk with your doctor about your options for managing anxiety.

* Chronic fatigue syndrome is usually called myalgic encephalomyelitis. It is not the same as mild fatigue (low energy).

The dosage of Abilify that a doctor prescribes may depend on several factors. These include:

• the kind and severity of the condition you’re taking the drug to treat
• your age
• your liver function
• side effects you may experience
• the form of Abilify you’re taking
• other conditions you may have (see “Dosage adjustments” in the “What is Abilify’s dosage?” section above)

You’ll swallow Abilify tablets once per day with or without food.

If you take Abilify MyCite tablets, you’ll also swallow them once per day with or without food. With this form of Abilify, you’ll also wear a MyCite Patch that has a sensor. The sensor in the patch receives information from the sensor in the tablet. It also sends information to a smartphone to help keep track of your dosages. Read more about this process on the drugmaker’s website and in the Abilify MyCite medication guide.

If you have trouble swallowing tablets, see this article for tips on how to take this form of medication.

With Abilify Maintena, a healthcare professional will give you the injection once per month. They will inject it into the muscle of your arm or buttock. Read more about this process on the drugmaker’s website.

For information on the expiration, storage, and disposal of Abilify, see this article.

Accessible drug containers and labels

Some pharmacies provide medication labels that:

• have large print or use braille
• feature a code you can scan with a smartphone to change the text to audio

Your pharmacy might offer these accessibility features. If they don’t, ask your doctor or pharmacist if they can recommend pharmacies that do.

If you have trouble opening medication bottles, let your pharmacist know. They may be able to supply Abilify in an easy-open container. They may also have tips to help make it simpler to open the drug’s container.

Read more about what to do in the event of an Abilify, Abilify MyCite, or Abilify Maintena missed dose.

Abilify and Abilify MyCite. If you miss your Abilify dose, take the dose when you remember. But if your next dose is due soon, skip the missed dose. Then take your next dose at the planned time. Do not take two doses at a time.

If you’re unsure whether to take a missed dose, check with your doctor or pharmacist.

Abilify Maintena. If you miss your Abilify Maintena injection, the action you’ll take depends on your dosage schedule. It also depends on the time that has passed since your last injection.

If you miss a second or third injection

• If 4 to 5 weeks have passed since your last injection, a healthcare professional may give the dose right away.
• If more than 5 weeks have passed since your last injection, you may need to restart the injection schedule. Your doctor may also prescribe oral Abilify for 2 weeks.

If you miss a fourth or later injection

• If 4 to 6 weeks have passed since your last injection, a healthcare professional may give the dose right away.
• If more than 6 weeks have passed since your last injection, you may need to restart the injection schedule. Your doctor may also prescribe oral Abilify for 2 weeks.

If you need help remembering to take your dose of Abilify on time, try using a medication reminder. This can include setting an alarm or downloading a reminder app on your phone. You can also use an alarm or reminder app to remind you of injection appointments.

Yes, there may be a risk of misuse with Abilify. Misuse was not reported in studies, but it is possible because the drug affects your mental state.

If you have a history of drug misuse or dependence, you may be at higher risk of these problems with Abilify. (With misuse, the drug is taken in a way that’s different from its prescribed use. With dependence, your body needs the drug to function as usual.)

Talk with your doctor about warning signs of misuse or dependence with Ability. These include developing a tolerance for the drug and unintentionally increasing your dosage.

Do not take more Abilify than your doctor prescribes, as this can lead to serious side effects.

Symptoms of overdose

Symptoms caused by an overdose can include:

• fast heartbeat
• convulsions
• heart rhythm changes
• aggression
• tremor
• sleepiness
• vomiting
• atypical lab test results
• blood pressure changes
• slowed breathing
• loss of consciousness
• coma

What to do in case you take too much Abilify

Call your doctor right away if you think you’ve taken too much Abilify. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 (or your local emergency number) or go to the nearest emergency room.

Some people who take Abilify may develop a dependence on the drug. (With dependence, your body needs the drug to function as usual. ) So Abilify may lead to withdrawal symptoms if you stop it abruptly.

Withdrawal symptoms include:

• fast heart rate
• nausea
• headache

You may also experience returning symptoms of your medical condition if you stop taking Abilify to treat it.

If you’re considering stopping Abilify treatment, talk with your doctor first. They will usually create a taper schedule for you to stop the drug. A taper schedule lowers your dosage gradually to decrease the risk of withdrawal symptoms.

The sections above describe the usual dosages provided by the drugmaker. If your doctor recommends Abilify for you, they’ll prescribe the dosage that’s right for you.

Remember, you should not change your dosage of Abilify without your doctor’s recommendation. Only take Abilify exactly as prescribed. Talk with your doctor if you have questions or concerns about your current dosage.

Here are some examples of questions you may want to ask your doctor:

• Does my dose of Abilify need to change because of other medications I take?
• What might increase the possibility of side effects?
• How fast will my Abilify dosage be increased?
• Should my oral dosage be for Abilify or Abilify MyCite?
• If Abilify is not working to manage my symptoms, should my dosage increase?

To learn more about Abilify, see these articles:

• All About Abilify
• Abilify Interactions: Alcohol, Medications, and Others
• Side Effects of Abilify: What You Need to Know
• Abilify and Cost: What You Need to Know
• Abilify vs. Rexulti: What You Should Know

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Memorial Sloan Kettering Cancer Center

Adult Medication

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Provided by Lexicomp ^® , this document contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Abilify; Abilify Asimtufii; Abilify Maintena; Abilify MyCite Maintenance Kit Abilify MyCite Starter Kit Abilify MyCite [DSC]

Trade names: Canada

Abilify; Abilify Maintena; APO-ARIPiprazole; Auro-ARIPiprazole; MINT-Aripiprazole; PMS-ARIPiprazole; RIVA-ARIPiprazole; SANDOZ ARIPiprazole; TEVA-ARIPiprazole [DSC]

Warning

• Older people who take this drug to treat dementia-related mental health problems have an increased risk of death. Most known deaths were due to heart disease or infection. This drug is not approved for the treatment of psychiatric problems associated with dementia.
• Drugs like this have increased the likelihood of suicidal thoughts or actions in children and young people. This risk may be higher in people who have tried or had suicidal thoughts in the past. All people taking this drug must be closely monitored. If you develop or worsen disorders such as depression, nervousness, anxiety, grouchiness, panic attacks, and changes in mood or behavior, contact your doctor immediately. Contact your doctor immediately if you have suicidal thoughts or suicide attempts.

What is this drug used for?

• The drug is used to treat schizophrenia.
• Used to treat bipolar disorder.
• Used to treat depression.
• It is used to treat certain behavioral disorders in patients with autism.
• This drug is used to treat Tourette’s syndrome.
• This drug may also be used for other indications. Consult your doctor.

What should I tell my doctor BEFORE taking this drug?

• If you have an allergy to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergies and how they have manifested.

Combining this drug with certain drugs and conditions may be unfavorable.

Tell your doctor and pharmacist about all medicines you take (prescription and over-the-counter, natural products and vitamins) and any health problems you have. You need to make sure that this drug is safe for your conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s advice.

What do I need to know or do while taking this drug?

All forms:

• Tell all your health care workers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• Avoid driving or doing other tasks or jobs that require alertness or keen eyesight until you know how this drug affects you.
• To reduce the risk of dizziness or loss of consciousness, get up slowly from a lying or sitting position. Walking up and down stairs should be done with care.
• If you have phenylketonuria, talk to your doctor. Some foods contain phenylalanine.
• If your body is unable to break down sucrose or fructose, talk to your doctor. Some preparations contain sucrose or fructose.
• Perform blood tests as directed by your doctor. Consult with your doctor.
• Avoid drinking alcohol while taking this drug.
• Check with your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that can slow you down.
• Caution should be exercised in hot weather and during vigorous activity. Drink plenty of fluids to prevent dehydration.
• Drink plenty of non-caffeinated fluids every day, unless your doctor has told you to drink less fluids.
• There may be an increased risk of seizures. It is necessary to consult a doctor.
• Against the background of taking drugs of this kind, a reduced level of leukocytes was noted. This can lead to an increased chance of infection. In rare cases, infections have been deadly. If you have ever had a low white blood cell count in the past, tell your doctor. Call your doctor right away if you have symptoms of an infection, such as a high fever, chills, or sore throat.
• High blood sugar or diabetes, high cholesterol and weight gain have been reported with medicines similar to this drug. These changes can increase the likelihood of developing vascular disease of the heart and brain.
• Check your blood sugar as directed by your doctor.
• The use of this drug may be accompanied by dizziness, drowsiness and a feeling of unsteadiness. Doing so may result in a fall, with the risk of broken bones or other health hazards.
• Elderly people with dementia who took similar drugs had an increased incidence of strokes. In some cases, this has led to death. This drug is not approved for the treatment of psychiatric problems associated with dementia.
• If you are 65 years of age or older, use this drug with caution. You may experience more side effects.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.
• Use of this drug in the third trimester of pregnancy may cause side effects or withdrawal symptoms in the newborn.

Tablets with sensor (Abilify MyCite):

• The patch may contain a conductive metal. Remove the patch before performing an MRI scan.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, this drug can cause serious and sometimes deadly side effects in some patients. Call your doctor right away or get medical help if you have any of the following signs or symptoms that could be associated with serious side effects:

All editions:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Signs of high blood sugar such as confusion, drowsiness, unusual thirst and hunger, increased urination, flushing, rapid breathing, and fruity breath.
• Uncontrolled body movements, jerky movements, balance problems, difficulty swallowing or speaking.
• Strong desires that are difficult to control (for example, eating, gambling, sex, or spending money).
• Severe dizziness or fainting.
• Balance change.
• Seizures.
• Blurred vision.
• A very severe, sometimes deadly, disorder called neuroleptic malignant syndrome (NMS) can occur. Call your doctor right away if you have a fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, tachycardia, feeling of an abnormal heartbeat, or excessive sweating.
• Some people can develop a serious muscle disorder called tardive dyskinesia. This effect may decrease or disappear after discontinuation of the drug, but may persist. People with diabetes and older age groups, especially older women, are at increased risk. The risk increases with long-term use or high doses, but may also occur with short-term low doses. Call your doctor right away if you experience uncontrolled body movements or muscle disorders of the tongue, face, mouth, or jaw, such as protruding tongue, puffy cheeks, puckered lips, or involuntary chewing movements.

Tablets with sensor (Abilify MyCite):

• Irritation of the skin at the site of application of the patch.

What are some other side effects of this drug?

Any medicine can have side effects. However, for many people, side effects are either minor or non-existent. Talk to your doctor or get medical help if these or any other side effects bother you or don’t go away:

All editions:

• Feeling dizzy, drowsy, tired or weak.
• Anxiety.
• Anxiety.
• Headache.
• Nausea or vomiting.
• Weight gain.
• Constipation.
• Sleep disorders.
• Appetite changes.
• Irritation of the nose or throat.
• Dry mouth.
• Shiver.
• Salivation.
• Stuffy nose.

Injection:

• Pain at the injection site.

This list of possible side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Board.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All oral preparations:

• Take this drug with or without food.
• Keep taking this drug as instructed by your doctor or other health care professional, even if you feel well.

Tablets:

• Swallow whole. Do not chew, break or crush.

Liquid:

• Liquid doses should be measured with caution. Use the dispenser that comes with the medication. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.

Lozenge:

• Do not squeeze the tablet out of the foil when opening. The tablet should be removed from the foil with dry hands. Put the tablet on your tongue and let it dissolve. It is not necessary to drink water. Do not swallow the tablet whole. Do not chew, break, or crush the tablet.

Tablets with sensor (Abilify MyCite):

• While you are taking this drug, you will also wear a patch with a sensor that will record when you take the pill. In addition, you will need to use a smartphone app. You must know how to take pills and where to put the patch, other information about the patch, and be able to use the smartphone app. Follow your doctor’s instructions. Detailed information is contained in the attached instructions. If you have any questions, ask your doctor.
• Swallow the tablets whole. Do not chew, break or crush.

Injection:

• For intramuscular injections.

What if I miss a dose of a drug?

All oral preparations:

• Take the missed dose as soon as you can.
• If it’s time for your next dose, don’t take the missed dose and then go back to your regular dosing schedule.
• Do not take 2 doses or an additional dose at the same time.

Injection:

• See your doctor for further instructions.

How do I store and/or discard this drug?

All oral preparations:

• Store at room temperature in a dry place. Do not store in the bathroom.

Liquid:

• Once opened, discard any unused servings after 6 months.

Lozenge:

• Use orally disintegrating tablets immediately after opening the package. Throw away any unused servings from an opened bag.

Injection:

• If you need to store this drug at home, check with your doctor, nurse, or pharmacist for storage conditions.

All forms:

• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your health does not improve or even worsens, see your doctor.
• Do not give your medicine to anyone and do not take other people’s medicines.
• Some medicines may come with other patient information leaflets. If you have any questions about this drug, talk with your doctor, nurse, pharmacist, or other health care professional.
• A separate instruction for patients is attached to the drug. Please read this information carefully. Reread it each time you refill your supply. If you have any questions about this drug, ask your doctor, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last revision date

2022-12-13

Copyright

© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Date last updated

Monday, December 12, 2022

Use of atypical antipsychotics in the treatment of depressive episodes in bipolar disorder | Streltsov

Introduction

Bipolar disorder is an endogenous affective disorder characterized by episodes of mania (hypomania) and depression [1]. There are currently two types of bipolar disorder: bipolar I disorder and bipolar II disorder [2]. Bipolar I disorder is manifested by mania and mixed states [3]. Type II bipolar disorder is manifested by depressive and hypomanic episodes. Manic episodes do not occur in this type of disorder.

Depressive episodes are more pronounced in type II bipolar disorder than in type I [4]. Depressive episodes are the leading manifestation of the disease in patients with bipolar disorder [5]. In a systematic literature review of long-term treated patients with bipolar I disorder, researchers concluded that depression accounts for approximately 70% of affective episodes [6].

The prevalence of bipolar disorder ranges from 1% to 2.4% [7]. The percentage of suicides in patients with bipolar disorder is 4 – 19% [8].

Problems in the treatment of depressive episodes in bipolar disorder

Adequate treatment of recurrent depressive episodes in bipolar disorder has long been a clinical problem, as antidepressants have not been able to demonstrate sufficient efficacy in bipolar depression in short-term and long-term studies [9].

Long-term treatment for bipolar type 2 disorder is primarily “prophylactic” in that it aims to prevent and/or reduce the frequency and severity of relapses of affective symptoms through a combination of pharmacological and complementary psychological interventions [10]. Compared to bipolar I disorder, there are limited studies demonstrating the sufficient efficacy of one treatment option over others in bipolar II disorder [11].

Use of atypical antipsychotics in bipolar depression

Lurasidone

affinity for the serotonin 5-HT1A receptor and the absence of a noticeable affinity for h2-histamine and M1-muscarinic receptors [12].

Ishigooka J., Kato T., Miyajima M. et al. conducted a 28-week safety and efficacy study with lurasidone. For this, patients were selected from a 6-week, double-blind, randomized study, in which patients were divided into three groups: taking the drug at dosages from 20 to 60 mg, taking 80-120 mg and taking placebo. Efficacy was assessed using the Montgomery Asberg Depression Rating Scale (MADRS). By the end of week 28, the overall mean MADRS score decreased as in the group previously treated with lurasidone for 6 weeks (by 8.9points) and in the group previously treated with placebo (by 11.3 points). Side effects included akathisia, headache, and drowsiness [13].

Raison C.L., Siu C., Pikalov A. et al. conducted a double-blind, 6-week, placebo-controlled study to investigate the association between pre-treatment levels of highly sensitive C-reactive protein (CRP) and changes in depressive symptoms and cognitive functioning in 10 patients – 17 years old with bipolar disorder. Patients were divided into groups taking flexible doses of lurasidone (20-80 mg) and groups taking placebo. The study found that patients with high baseline CRP levels responded better to lurasidone treatment than those with low baseline CRP levels, but only in patients with normal or low body mass index (BMI) levels. Lurasidone was more effective than placebo regardless of baseline CRP [14].

Cariprazine

Cariprazine is a partial agonist of dopamine receptors D ₂ and D ₃ , and serotonin receptor 5-HT _1A [1 5]. The unique affinity for the D ₃ receptor may mediate the anti-anhedonic, procognitive, and antidepressant effects of cariprazine [16][17].

Durgam S., Earley W., Lipschitz A. et al. conducted an 8-week, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cariprazine in patients with major depressive episodes in bipolar disorder. Patients were randomly assigned to either placebo or cariprazine at doses of 0.75, 1.5, and 3.0 mg/day. Efficacy was assessed using the MADRS and the severity subscale of the Global Clinical Impression Scale (GCI-S). Cariprazine at 1.5 mg/day showed a significant reduction in MADRS scores from baseline at study week 6 compared with placebo (least squares mean difference was -4.0). When taking cariprazine at a dosage of 3 mg/day, the difference in the mean least squares was -2. 5. The 0.75 mg daily dose was similar to the placebo dose.

The most commonly reported adverse events in patients treated with cariprazine were akathisia and insomnia. Weight gain was slightly higher in patients treated with cariprazine than with placebo [18].

Another double-blind, placebo-controlled study of the safety and efficacy of cariprazine by Earley W., Burgess M.V., Rekeda L. et al. reported similar results. Patients aged 18 to 65 years who met the DSM-5 criteria for bipolar I disorder with a current depressive episode were selected for the study. Patients were divided into three groups: taking 3 mg cariprazine per day, taking 1.5 mg cariprazine per day and taking placebo. Efficacy was assessed using MADRS and GCI-S. After 6 weeks, data were obtained that both doses of cariprazine were significantly more effective than placebo. Both doses of cariprazine were associated with lower CGI-S scores compared with placebo, but the differences did not reach statistical significance. Side effects in the groups taking cariprazine were recorded twice as often as in the placebo group. The most common side effects were nausea, akathisia and dizziness [19].

Olanzapine

Olanzapine is a drug with affinity for serotonin 5-HT _2A , 5-HT _2C , 5-HT HT ₆ , D ₁ , D ₂ , D ₃ , D ₄ and D ₅ , muscarinic, adrenergic α ₁ and histamine H ₁ receptors [20].

Katagiri H., Tohen M., McDonnell D.P. et al. conducted a 6-week, double-blind, randomized trial of the efficacy and safety of olanzapine in bipolar depression. Compared with placebo, patients in the olanzapine group showed a decrease in MADRS scores. But in this group, side effects were more common, such as weight gain, increased levels of cholesterol, triglycerides, low-density lipoproteins, and a decrease in high-density lipoproteins [21].

Pan P.Y., Lee M. S., Lo M.C. found that olanzapine
was more effective than lamotrigine in preventing
depressive episodes in patients with bipolar disorder [22].

Quetiapine

Quetiapine is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2 receptors [23].

Kishi T., Ikuta T., Matsuda Y. et al. studied the efficacy and safety of extended-release quetiapine 300 mg/day and olanzapine 5–20 mg/day in patients with bipolar depression using Bayesian analysis. As a result, it was found that there is no significant difference in effectiveness between the drugs. In patients treated with quetiapine, drowsiness was a common side effect, and in the olanzapine group, frequent side effects were: weight gain, increased blood prolactin levels, and decreased high-density lipoprotein levels [24].

Simon J., Geddes J.R., Gardiner A. conducted a multicentre, double-blind, placebo-controlled study comparing quetiapine alone versus quetiapine plus lamotrigine. It was found that the combination of quetiapine with lamotrigine was more effective than quetiapine alone [25].

Risperidone

Lindström L., Lindström E., Nilsson M. et al. conducted a meta-analysis of 15 RCTs to investigate the efficacy of atypical neuroleptics from 6 months to 4 years in bipolar disorder in 6142 patients. As monotherapy, olanzapine, quetiapine, and risperidone were found to be superior to placebo in reducing the overall risk of relapse [26].

A retrospective study of the effectiveness of taking risperidone to reduce the risk of affective episodes in patients with bipolar disorder showed that additional administration of the drug reduced the risk of developing manic episodes, but did not reduce the risk of developing depressive episodes [27].

In the course of comparing the safety of quetiapine and risperidone in patients with bipolar disorder, it was found that when taking risperidone, side effects such as weight gain, increased prolactin levels were detected [28].

Aripiprazole and ziprasidone

Bahji A., Ermacora D., Stephenson C. et al. conducted a systematic review and meta-analysis of RCTs on the efficacy and safety of pharmacological therapy for bipolar depression. During which 50 studies with 11448 patients were analyzed. aripiprazole and ziprasidone were ineffective compared with placebo in the treatment of bipolar depression. Aripiprazole had more side effects than placebo.

Olanzapine, quetiapine, and cariprazine were more effective than placebo in the treatment of bipolar depression [29].

In another systematic review and meta-analysis conducted to investigate the efficacy and safety of aripiprazole in bipolar disorder, it was found that the drug was effective in the treatment of mania, psychosis, but did not show efficacy in the treatment of bipolar depression [30].

Conclusion

Lurasidone, cariprazine, olanzapine, and quetiapine were significantly more effective than placebo.

Risperidone, aripiprazole and ziprasidone have been shown to be ineffective in the treatment of bipolar depression.

Olanzapine causes more serious side effects (weight gain, increased cholesterol, triglycerides, low-density lipoprotein and decreased high-density lipoprotein) than lurasidone, cariprazine, and quetiapine.

Combination of quetiapine with lamotrigine is more effective than antipsychotic alone.

In normal weight children and adolescents with higher pre-treatment CRP levels, lurasidone was associated with a better response to antidepressant therapy than placebo. CRP and BMI may be useful diagnostic and prognostic biomarkers in the treatment of children and adolescents with bipolar depression with lurasidone.

1. Tondo L, Vázquez GH, Baldessarini RJ. Depression and Mania in Bipolar Disorder. Curr Neuropharmacol. 2017;15(3):353-358. DOI: 10.2174/1570159X14666160606210811

2. Geddes JR, Miklowitz DJ. treatment of bipolar disorder. Lancet. 2013;381(9878):1672-82. DOI: 10.1016/S0140-6736(13)60857-0

3. Zargar F, Haghshenas N, Rajabi F, Tarrahi MJ. Eff ectiveness of Dialectical Behavioral Thrapy on Executive Function, Emotional Control and Severity of Symptoms in Patients with Bipolar I Disorder. Adv Biomed Res. 2019;8:59. DOI: 10.4103/abr.abr_42_19

4. Novick DM, Swartz HA. Evidence-Based Psychotherapies for Bipolar Disorder. Focus (Am Psychiatr Publ). 2019;17(3):238-248. DOI: 10.1176/appi.focus.201

5. Baldessarini RJ, Vieta E, Calabrese JR, Tohen M, Bowden CL. Bipolar depression: overview and commentary. Harv Rev Psychiatry. 2010;18(3):143-57. DOI: 10.3109/10673221003747955

6. Forte A, Baldessarini RJ, Tondo L, Vázquez GH, Pompili M, Girardi P. Long-term morbidity in bipolar-I, bipolar-II, and unipolar major depressive disorders. J Affect Disord. 2015;178:71-8. DOI: 10.1016/j.jad.2015.02.011

7. Rowland TA, Marwaha S. Epidemiology and risk factors for bipolar disorder. TherAdv Psychopharmacol. 2018;8(9):251-269. DOI: 10.1177/2045125318769235

8. Dome P, Rihmer Z, Gonda X. Suicide Risk in Bipolar Disorder: A Brief Review. Medicine (Kaunas). 2019;55(8):403. DOI: 10.3390/medicina55080403

9. Liu B, Zhang Y, Fang H, Liu J, Liu T, Li L. Efficacy and safety of long-term antidepressant treatment for bipolar disorders – A meta-analysis of randomized controlled trials. J Affect Disord. 2017;223:41-48. DOI: 10.1016/j.jad.2017.07.023

10. Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2016;387(10027):1561-1572. DOI: 10.1016/S0140-6736(15)00241-X

11. Yatham LN. Diagnosis and management of patients with bipolar II disorder. J Clin Psychiatry. 2005;66 Suppl 1:13-7.PMID: 15693747.

12. Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, et al. Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity. J Pharmacol Exp Ther. 2010;334(1):171-81. DOI: 10.1124/jpet.110.167346

13. Ishigooka J, Kato T, Miyajima M, Watabe K, Masuda T, et al. Lurasidone in the Long-Term Treatment of Bipolar I Depression: A 28-week Open Label Extension Study. J Affect Disord. 2021;281:160-167. DOI: 10.1016/j.jad.2020.12.005

14. Raison CL, Siu C, Pikalov A, Tocco M., Loebel A. C-reactive protein and response to lurasidone treatment in children and adolescents with bipolar I depression: Results from a placebo-controlled trial. Brain Behav Immun. 2020;84:269-274. DOI: 10.1016/j.bbi.2019.12.010

15. Duric V, Banasr M, Franklin T, Lepack A, Adham N, et al. Cariprazine Exhibits Anxiolytic and Dopamine D3 Receptor- Dependent Antidepressant Effects in the Chronic Stress Model. Int J Neuropsychopharmacol. 2017;20(10):788-796. DOI: 10.1093/ijnp/pyx038

16. Neill JC, Grayson B, Kiss B, Gyertyán I, Ferguson P, Adham N. Effects of cariprazine, a novel antipsychotic, on cognitive defi cit and negative symptoms in a rodent model of schizophrenia symptomatology. Eur Neuropsychopharmacol. 2016;26(1):3-14. DOI: 10.1016/j.euroneuro.2015.11.016

17. Watson DJG, King MV, Gyertyán I, Kiss B, Adham N, Fone KCF. Th e dopamine D₃-preferring D₂/D₃ dopamine receptor partial agonist, cariprazine, reverses behavioral changes in a rat neurodevelopmental model for schizophrenia. Eur Neuropsychopharmacol. 2016;26(2):208-224. DOI: 10.1016/j.euroneuro.2015.12.020

18. Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, et al. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016;173(3):271-81. DOI: 10.1176/appi.ajp.2015.15020164

19. Earley W, Burgess MV, Rekeda L, Dickinson R, Szatmári B, et al. Cariprazine Treatment of Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2019;176(6):439-448. DOI: 10.1176/appi.ajp.2018.18070824

20. Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, et al. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161(2 Suppl):1-56. PMID: 15000267.

21. Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, et al. Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Japanese subpopulation analysis of a randomized, double-blind, placebo-controlled study. BMC Psychiatry. 2013;13:138. DOI: 10.1186/1471-244X-13-138

22. Pan PY, Lee MS, Lo MC, Yang EL, Yeh CB. Olanzapine is superior to lamotrigine in the prevention of bipolar depression: a naturalistic observational study. BMC Psychiatry. 2014;14:145. DOI: 10.1186/1471-244X-14-145

23. Sanford M, Keating GM. Quetiapine: A review of its use in the management of bipolar depression. CNS Drugs. 2012;26(5):435-60. doi: 10.2165/11203840-000000000-00000

24. Kishi T, Ikuta T, Matsuda Y, Iwata N. Quetiapine extendedrelease vs olanzapine for Japanese patients with bipolar depression: A Bayesian analysis. Neuropsychopharmacol Rep. 2019;39(3):256-259. DOI: 10.1002/npr2.12070

25. Simon J, Geddes JR, Gardiner A, Rendell J, Goodwin GM, Mayer S. Comparative economic evaluation of quetiapine plus lamotrigine combination vs quetiapine monotherapy (and folic acid vs placebo) in patients with bipolar depression (CEQUEL). Bipolar Discord. 2018;20(8):733-745. DOI: 10.1111/bdi.12713

26. Lindström L, Lindström E, Nilsson M, Höistad M. Maintenance therapy with second generation antipsychotics for bipolar disorder – A systematic review and metaanalysis. J Affect Disord. 2017;213:138-150. DOI: 10.1016/j.jad.2017.02.012

27. Valdes M, Bertolin S, Qian H, Wong H, Lam RW, Yatham LN. Risperidone adjunctive therapy duration in the maintenance treatment of bipolar I disorder: A post hoc analysis. J Affect Disord. 2019;246:861-866. DOI: 10.1016/j.jad.2019.01.003

28. Masi G, Milone A, Stawinoga A, Veltri S, Pisano S. Efficacy and Safety of Risperidone and Quetiapine in Adolescents With Bipolar II Disorder Comorbid With Conduct Disorder.