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Abilify in kids: aripiprazole | CS Mott Children’s Hospital


Abilify: Anti-Psychotic Medications Overview, Uses

What Is the Medication Abilify?

Abilify (generic name: aripiprazole) is an anti-psychotic medication primarily used to treat symptoms of schizophrenia in patients over age 13, bipolar disorder in patients over age 10, depression in adults, irritability associated with autism in children over age six, and Tourette’s Syndrome in children over age six. Studies suggest that aripiprazole may have a dopamine-stabilizing effect on patients with ADHD1; some clinicians include it in ADHD treatment plans for both adults and children, particularly those who do not respond to stimulants2.

The safety and effectiveness of taking Abilify to treat depression or the agitation associated with schizophrenia or bipolar mania in children has not been established. Abilify can be dangerous for elderly people with dementia.

How to Use the Medication Abilify

Before starting or refilling an Abilify prescription, read the medication guide included with your pills, as it may be updated with new information.

This guide should not replace a conversation with your doctor, who has a holistic view of your medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.

Dosage for Abilify

As with all medications, follow your Abilify prescription instructions exactly. The optimal dosage varies by age and condition treated. Abilify is available in several formulations:

  • Abilify Tablets are available in 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg dosages. Tablets should be swallowed whole with water or another liquid.
  • Abilify DISCMELT (Orally Disintegrating Tablets): To keep it from dissolving before you place the tablet in your mouth, leave it contained in its blister package until you are ready to take it. When opening the medication, make sure your hands are clean and dry so as not to accidentally trigger dissolution. Peel back the blister package backing to take out the tablet, instead of pushing it through the foil. Place the tablet on your tongue to dissolve. Do not crush or chew the tablet. Orally disintegrating tablets are available in 10mg and 15 mg dosages. It is recommended they are taken without liquid.
  • Abilify Oral Solution: Colorless, orange-flavored liquid. The liquid should be measured with the included device and swallowed entirely with water or another liquid. The oral solution is available in a concentration of 1mg/mL.
  • Abilify Injection: The intramuscular injection is available in 9.75mg/1.3mL single dose vials.

The oral formulations are taken once daily, with our without food. Oral formulations are indicated for every condition except the agitation associated with schizophrenia or bipolar mania.

The injection should be taken no more than once every two hours, with a maximum daily dosage of 30mg. The injection is only indicated to treat the agitation associated with schizophrenia or bipolar mania.

If you miss a dose, you should take it as soon as possible, unless it is already time for your next dose. You should not take two doses of Abilify at the same time. Contact your doctor if you have questions about skipped pills.

When discontinuing treatment, or decreasing dosage, patients should work with a doctor to gradually taper the level of medication. Stopping Abilify suddenly can create new, serious symptoms.

Side Effects Associated with Abilify

The most common side effects of Abilify are as follows:

Children and Adolescents (ages 10 to 17): sleepiness, headache, vomiting, fatigue, changes in appetite, increased saliva, insomnia, nausea, stuffy nose, weight gain, uncontrolled movement, and muscle stiffness.

Adults: nausea, vomiting, constipation, headache, blurred vision, upper respiratory illness, dizziness, anxiety, insomnia, and restlessness.

Elderly people with dementia-related psychosis are at increased risk of death from stroke when treated with Abilify.

Medications like Abilify can increase risk of suicide and suicidal thoughts, especially at the start of treatment. Report to your healthcare provider any sudden changes in mood, including depression, anxiety, restlessness, panic, irritability, impulsivity, or aggression.

Other serious side effects include low white blood cell count, seizures, dyslipidemia, problems regulating body temperature, and pathological gambling or other compulsive behaviors.

Taking Abilify may impair your ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor.

Most people taking this medication do not experience any of these side effects.

Abilify can increase a patient’s risk of neuroleptic malignant syndrome (NMS). This is a rare, but serious condition that can cause a stroke resulting in death. If you experience high fever, sweating, rigid muscles, confusion, or changes in breathing or heartbeat, these could be warning signs of NMS and you should seek medical help at a hospital immediately.

Tell your doctor if you have diabetes or difficulty managing your blood sugar. Taking Abilify can increase blood sugar which, when untreated, can cause ketoacidosis, coma, or death. Warning signs of hyperglycemia include: excessive thirst, frequent urination, feeling very hungry, weak, tired or nauseous, fruit-scented breath, and nausea. If you experience these, contact your healthcare provider.

Some people experience tardive dyskinesia, a condition which causes uncontrollable movements in the face, tongue, or other body parts. This may not go away, even if you stop taking Abilify.

While taking Abilify, your doctor should regularly monitor the fat levels in your blood (cholesterol and triglycerides), weight, and blood pressure. Abilify can increase blood fat levels, cause weight gain, and create sudden changes in blood pressure, especially in children and teenagers.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

Precautions Associated with Abilify

Store Abilify in a secure place out of the reach of children, and at room temperature. Do not share your Abilify prescription with anyone, even another person with schizophrenia or bipolar disorder. Sharing prescription medication is illegal, and can cause harm.

You should not take Abilify if you have an allergy to aripiprazole or any of the ingredients in Abilify. Before taking Abilify, tell your doctor if you have a personal or family history of diabetes, abnormal blood pressure, low white blood cell count, or heart problems.

Do not become overheated or dehydrated while taking Abilify. This includes avoiding extremely strenuous exercise, spending time in the sun, or wearing too-heavy clothing.

If you’re thinking of becoming pregnant, discuss the use of Abilify with your doctor. Especially when taken in the last three months of pregnancy, it is suspected to cause fetal harm. It is recommended that mothers do not nurse while taking Abilify, as it is unsafe for infants, and Abilify passes into breastmilk.

Interactions Associated with Abilify

Before taking Abilify, discuss all other active prescription medications with your doctor.

Medications that inhibit or induce CYP2D6 or CYP3A4, enzymes that metabolize certain drugs, can increase or decrease how the body absorbs Abilify. Physicians may need to increase or decrease Abilify dosage when taken with prescriptions like itraconazole, fluoxetine, carbamazepine, rifampin, and lorazepam.

Share a list of all vitamin or herbal supplements, prescription, and non-prescription medications you take with the pharmacist when you fill your prescription, especially any drugs that cause drowsiness. Let all doctors and physicians know you are taking Abilify before having any surgery or laboratory tests.

The above is not a complete list of all possible drug interactions.

1Robert L Findling, MD. “The Cognitive Effects of Aripiprazole in Children.” University Hospital Case Medical Center. 2005-2014
2Dr.Yannick Pauli. “Abilify for ADHD: An Antipsychotic with Worrisome Side Effects” Dr. Yannick Pauli’s UnRitalin Solution. (2010). Web. (http://www.unritalinsolution.com/adhdblog/2010/06/28/abilify-for-adhd/)



Aripiprazole for schizophrenia, bipolar disorder and tics

Aripiprazole for schizophrenia, bipolar disorder and tics

This leaflet is about the use of aripiprazole for the treatment of schizophrenia and bipolar disorder (sometimes called psychotic disorders) and tics, such as seen in Tourette’s syndrome.

This leaflet has been written for parents and carers about how to use this medicine in children. Our information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adult patients. Please read this leaflet carefully. Keep it somewhere safe so that you can read it again.

Do not stop giving aripiprazole suddenly, as your child is likely to get withdrawal symptoms.

Name of drug

Aripiprazole (AR-i-PIP-ra-zole)
Brand name: Abilify®

Why is it important for my child to take this medicine?

Aripiprazole changes the levels of some important chemicals in the brain such as dopamine and serotonin. 

  • For children with schizophrenia or bipolar disorder, aripiprazole can reduce your child’s symptoms and help their mood and behaviour to be more stable.
  • For children with tics, aripiprazole will help to reduce the severity and frequency of tics.

Read more about what a ‘tic’ is here: www.nhs. uk/conditions/tics/

What is aripiprazole available as?

  • Tablets: 5 mg, 10 mg, 15 mg, 30 mg; these contain lactose
  • Orodispersible tablets: 10 mg, 15 mg; these contain a small amount of aspartame
  • Liquid medicine: 5 mg in 5 mL

When should I give aripiprazole?

Aripiprazole is usually given once a day. This is usually in the morning.
Give the medicine at about the same time each day so that this becomes part of your child’s daily routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of aripiprazole (the dose) that is right for your child. The dose will be shown on the medicine label. 

Your doctor may suggest that your child has a low dose to start with. They may then increase the dose as your child gets used to the medicine and depending on how your child responds to it.

It is important that you follow your doctor’s instructions about how much to give.

How should I give it? 

Tablets should be swallowed with a glass of water, milk or juice. Your child should not chew the tablet.

Orodispersible tablets: Ensure your hands are dry before removing the tablet from the pack. Put it on your child’s tongue straight away. The tablet will dissolve rapidly. You can also dissolve it in a glass of water. Your child should drink it all straight away.  

Liquid medicine: Measure out the right amount using an oral syringe or medicine spoon. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.

When should the medicine start working?

This depends on what your child is being treated for. 

  • If your child has been agitated as part of their illness, this should decrease after taking an adequate dose of aripiprazole for a few days.
  • If your child is being treated for elated mood (being extremely happy), they should seem calmer after about a week of reaching the adequate dose. 
  • If your child gets hallucinations (seeing or hearing things that are not there), these should start to get better after about 2 weeks. It may take longer than this for delusions (believing something to be real that is not) to stop. It may take 6–8 weeks before your child’s mood and behaviour seem more normal. 
  • If your child is being treated for tics or Tourette’s syndrome, it is likely to take 4–6 weeks for symptoms to get better.

It is important that you continue to give the medicine every day, as your doctor has told you to. However, as the medicine may not work sufficiently in some children, if you are concerned about whether it is working, contact your doctor..

What if my child is sick (vomits)? 

  • If your child is sick less than 30 minutes after having a dose of aripiprazole, give them the same dose again.
  • If your child is sick more than 30 minutes after having a dose of aripiprazole, you do not need to give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your GP, nurse, pharmacist or hospital. They will decide what to do based on your child’s condition and the specific medicine involved.

What if I forget to give it?

Give the missed dose when you remember during the day, as long as this is at least 12 hours before the next dose is due.

Never give a double dose of aripiprazole. 

What if I give too much?

It may be dangerous to give too much aripiprazole.

If you think you may have given your child too much aripiprazole, contact your doctor or your local NHS services (111 in England and Scotland; 0845 4647 in Wales) or take your child to hospital.
Take the medicine container or packaging with you, even if it is empty. This will be useful to the doctor. Have the medicine or packaging with you if you telephone for advice.

Are there any possible side-effects? 

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects).

Side-effects you must do something about

Contact your doctor straight away if your child has any of the following:

  • muscle spasms (stiffening of the muscles), twitching in the face and body, or uncontrolled movements of the tongue or jaw
  • they become restless and cannot control their movements
  • fever, sore throat, rash or mouth ulcers.

Other side-effects you need to know about

  • Your child may feel sleepy, tired or weak when they first start taking this medicine. These effects usually wear off as your child’s body gets used to the medicine If they are still a problem after 2 weeks, contact your doctor.
  • Your child may get stomach ache and feel sick. They may also get constipated (have difficulty doing a poo). Make sure they eat food that contains fibre (e.g. bran, wholemeal bread, rice, pasta, fruit and vegetables) and that they drink plenty of fluid. If this is still a problem after 2 weeks, contact your doctor. 
  • Your child may feel light-headed or dizzy when they stand up, or may faint. This is because aripiprazole may lower the blood pressure. They should stand up slowly, and should lie down for a while if they feel dizzy. If this becomes a problem, contact your doctor, as your child’s blood pressure may be too low.
  • Your child may find that their eyesight seems blurred. If this carries on for longer than 2 weeks, contact your doctor. 
  • Your child’s appetite may increase and this may result in weight gain.
  • Your child’s skin will be more sensitive to sunlight and they are more likely to get sunburn. When outdoors they should keep their skin covered, use high-factor sun screen and wear a hat, especially in the summer.
  • Rarely, your child may feel very low (depressed) or have thoughts about suicide. Contact your doctor if this happens.

Can other medicines be given at the same time?

  • You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
  • Aripiprazole should not be taken with some medicines that you get on prescription. Tell your doctor and pharmacist about any other medicines your child is taking before giving aripiprazole. 
  • Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

Is there anything else I need to know about aripiprazole?

Do not suddenly stop giving your child aripiprazole, as they may get withdrawal symptoms (difficulty sleeping, tremor, anxiety, nausea and vomiting).

  • If you or your child wants to stop aripiprazole, discuss this with your doctor. They may want to reduce the dose slowly so that your child doesn’t get withdrawal symptoms.   

Do not change the dose without talking to your doctor first.

  • Teenagers should be aware that if they drink alcohol while taking aripiprazole, the effects will be stronger. Ideally, they should not drink alcohol.
  • Aripiprazole can affect the ability to do skilled tasks such as driving. 

General advice about medicines

  • Try to give the medicine at about the same time each day, to help you remember.
  • Only give this medicine to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm. 

If you think someone else may have taken the medicine by accident, contact your doctor straight away.

  • Make sure that you always have enough medicine. Order a new prescription at least 2 weeks before you will run out.
  • Make sure that the medicine you have at home has not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.

Where should I keep this medicine?

  • Keep the medicine in a cupboard, away from heat and direct sunlight. It does not need to be kept in the fridge.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.
  • The liquid medicine does not keep for long once it has been opened. Write the date that you start it on the bottle.

Who to contact for more information 

Your doctor, pharmacist or nurse will be able to give you more information about aripiprazole and about other medicines used to treat psychotic disorders and tics.

What Parents Should Know About Risperdal

Risperdal is a medication that’s widely used to treat children who are aggressive or excessively irritable. Though it was originally approved to treat psychosis, its use in children, including those with autism or ADHD diagnoses, has grown dramatically over the last two decades. That’s because Risperdal can successfully calm down kids with severe behavior problems, enabling them to function in school and within their families. Without it, some would require residential treatment.

But Risperdal (generic name risperdone) can have serious side effects, and it’s important to make sure a child taking it is monitored carefully. Parents should know what the medical community agrees are the “best practices” to be followed by a doctor who prescribes Risperdal, to insure good treatment.
Here are the basics about Risperdal: what it’s used for, potential side effects, and how a child on Risperdal should be monitored.

What is Risperdal for?

Risperdal is what is called an atypical, or second-generation antipsychotic (SGA). It was a new kind of antipsychotic approved by the Federal Drug Administration in the 1990s to treat the symptoms of psychosis in schizophrenia and bipolar disorder.

Now it is more widely used to treat aggression and irritability in both dementia patients, often in inpatient facilities, and in children.

Many kids on the autism spectrum take Risperdal to reduce behavior problems like aggression or self-injury, and the FDA has approved it for that use. But it’s also prescribed to many kids who have ADHD (attention-deficit hyperactivity disorder), ODD (oppositional defiant disorder) or DMDD (disruptive mood dysregulation disorder).

When kids act out dangerously or are at risk of getting kicked out of school or removed from the home, they may be given Risperdal or another SGA to calm them down. For kids who do not have an autism diagnosis, these prescriptions are off-label — that is, they are not an FDA-approved use for the drug. But a substantial body of evidence suggests they are effective in reducing persistent behavioral problems.

Why is Risperdal controversial?

Risperdal is controversial because side effects that include substantial weight gain and metabolic, neurological and hormonal changes that can be harmful. Some experts are concerned that children are being treated with the drug in lieu of other treatment — including behavioral treatment — that could be effective without the risk of these side effects.

Risperdal has been in the news over the last several years because of thousands of lawsuits from families who say they were not informed about side effects that might adversely affect their kids, and the kids were not taken off the medication when problems developed. Many of the suits are on behalf of boys who, in a rare side effect, developed breasts because of an increase in a hormone called prolactin.

Problems in school and at home

Wendy Nash, MD, a child and adolescent psychiatrist at the Child Mind Institute, describes a common scenario in which Risperdal is prescribed because a child’s aggressiveness or irritability has become acutely problematic. This behavior often presents in early adolescence, says Dr. Nash. “These are kids who are very aggressive, meaning they might push, shove, punch, break furniture.”

When these kids can’t control their tempers, they may be a danger to other children, their parents and themselves. “Sometimes their parents are so desperate they have considered calling 911,” Dr. Nash notes. Or the child might already have been sent to the emergency room after an outburst at school.

For kids in crisis, Risperdal is often clinicians’ first choice for stabilizing the situation. If it’s not a crisis, they recommend that other treatments be tried first.

Behavioral therapy

Most experts, including Dr. Nash, stress the importance of thoroughly investigating the causes of aggressive behavior as part of the evaluation for medication. Behavior problems can have many different sources, including undiagnosed anxiety, ADHD, learning disorders, trauma and medical problems. Treating those problems may allieviate the behavior issues in a more effective (and lasting) way than giving the child antipsychotic medication.

For children with disruptive behavior problems that haven’t reached a crisis stage, experts’ first choice  for treatment is behavioral therapy, including parent training, to rein things in. Depending on the level of risk, Dr. Nash says she might recommend a first trial of behavioral therapy, or medication together with behavioral therapy.

Related: Choosing a Parent Training Program

Alternative medications

In a more stable situation, Dr. Nash also favors first trying more targeted medications with fewer side effects. For instance, in a child with ADHD, stimulants (Ritalin or Aderall) or non-stimulant ADHD medications like clonidine (Catapres, Kapvay, Nexiclon) or guanfacine (Estulic, Tenex, Intuniv) could reduce impulsive aggression. For a child with ODD, she says, antidepressants (SSRIs) can help with underlying depression or anxiety that could trigger outbursts.

If these attempts are not effective, Dr. Nash may try an SGA. Abilify (aripiprazole), which is also approved for irritability in kids on the spectrum and commonly used for aggression, is usually her first choice, because it has fewer side effects, than Risperdal, including lower weight gain and endocrine disruption. But medication treatment should always be in combination with behavioral therapy, she stresses, which could include parent training.

The medical community agrees. A survey of treatment recommendations from top experts emphasizes that medication should not replace behavioral therapy.

After kids are stabilized

Experts note that a child who’s been put on an SGA in a crisis might be transitioned to a different treatment after the situation is stabilized. In Dr. Nash’s experience, children who participate in behavioral therapy may later be able to stop taking the medication. “My preference is to use risperidone in a time-limited way, to settle the crisis,” she explains. “In the meantime, I’m setting up parent management training.”

Michael Milham, MD, PhD, a child and adolescent psychiatrist at the Child Mind Institute, also uses SGAs to stabilize children in crisis situations. He notes that it’s critical to not take kids off the medications without other supports in place, such as behavioral therapy, including parent training.

“It’s important to know when to try to take kids off it — and it’s not as soon as things are going well,” explains Dr. Milham. “They need to be stable, and have other interventions in place. Otherwise you’re just going to recreate the problem, and the kids end up in the ER.”

Risperdal side effects

Weight gain

The most common side effect of Risperdal is weight gain, which can occur quickly. In one study, average weight gain after 10.8 weeks of treatment with Risperdal was 11.7 pounds, compared to just .44 pounds in children taking a placebo. In a study of children treated with Risperdal for 2.9 years, a third were either overweight or obese. Larger doses were associated with significantly greater increases in weight.

Metabolic side effects

Risperdal may also cause what are called “metabolic abnormalities,” including a rise in blood sugar, lipids and trygilicerides that increase the risk of diabetes and heart disease in later life. These are more common in overweight or obese children.

Of the SGAs, the risk of metabolic side effects is greatest with Zyprexa (olanzapine), followed by Clozaril (clozapine). Seroquel (quetiapine) and Risperdal fall into the middle. On the lower end is Abilify, Geodon (ziprasidone) and Latuda (lurasidone).

Neurological side effects

Another set of possible side effects include something called “tardive dyskinesia,” which is characterized by repetitive, involuntary movements, including facial grimaces. The risk of tardive dyskinesia increases with the dose and duration of the treatment, and it can be permanent. The risk of neurological side effects is greatest with Risperdal, Zyprexa and Abilify.

Hormonal side effects

The side effect that sparked the lawsuits against Johnson & Johnson, Risperdal’s maker, is an increase in a hormone called prolactin. Elevated prolactin is called hyperprolactinemia. Prolactin normally causes breast enlargement during pregnancy and milk secretion during breastfeeding. In girls, hyperprolactinemia can lead to breast enlargement, production of breast milk, and bone loss. In boys it can interfere with sperm production and cause breast growth, called gynecomastia.

Studies show that in kids taking antipsychotics, prolactin levels rise until around around 6 to 8 weeks (peaking at, in one study, four times higher than those treated with placebo), and then drop back toward normal. Higher doses of Risperdal — rather than longer use — appear to be linked to elevated prolactin levels.

But not all children who have elevated prolactin develop symptoms. Hyperprolactinemia is common (1.0 to 10 percent of patients develop it) but hormonal symptoms like gynecomastia are uncommon (0.1 to 1.0 percent).

Of the second-generation antipsychotics, Risperdal shows the greatest increase in prolactin levels, and Abilify the least.

Monitoring for side effects

Children taking Risperdal or another atypical antipsychotic should be monitored by their doctors regularly over the course of treatment. Before treatment begins, they should be tested to establish baselines for height, weight, vital signs, and levels of prolactin and blood fats and sugar.

Prolactin levels should be measured frequently during the first few months of treatment. If the child has elevated prolactin and shows symptoms of hyperprolactinemia, it’s recommended that the dose be tapered off and the child be switched to another SGA. If a child has elevated prolactin but shows no symptoms, it’s recommended that he continue to be monitored on a yearly basis if he is using the medication long-term, as prolonged effects of elevated prolactin on fertility and bone development are not known.

A group of Canadian researchers note that yearly lab tests with a physical exam for stable patients may seem like a waste of time to busy clinicians. But given the potential consequences, they add, “Clinicians who are unprepared to monitor children for side effects should choose not to prescribe these medications.”

Working with your doctor

As with any medication, it is important to talk to your doctor about any concerns you have. Your child’s clinician should be ready to discuss the symptoms you are seeing and explain potential options for changing dosage or medication. If you don’t feel that your child’s doctor is taking your concerns seriously, or your doctor is not following best practices for changing dosage, or adding new medications, you should get a second opinion.

If you believe your child should stop taking Risperdal, make sure you tell your doctor, and discuss the pros and cons. Don’t make adjustments or withdraw the medication without consultation. Antipsychotic medications should be reduced gradually, and the child should be monitored for side effects of withdrawing too quickly, including runny nose, diarrhea and cramping. And remember: The biggest concern to watch for is the return of dangerous behavior that the medication was prescribed to treat in the first place.

Antipsychotics, Weight Gain and Kids’ Health

Medications generally have side effects that can be mild, moderate, or severe. Most psychiatric medications can cause some weight gain. Antipsychotics that are being used now for a number of conditions are more on the higher end of causing weight gain, although not all antipsychotics cause the same degree of weight gain.

We have pretty good probabilities which have the highest degree of weight gain, and also which have the highest degree of metabolic abnormalities that are either related to the weight gain, or can occur just because of the medication. By “metabolic” I mean changes in blood sugar and blood fats that have a negative outcome on the risk for cardiovascular illness, similar to the weight gain, later on.

We’ve very concerned about this side effect cluster because of its potential negative effect on cardiovascular risk factors and illness like diabetes, heart attack, stroke, in the future. The worry is that if weight gain occurs early in life, these occurrences that happen usually late in life might happen in mid-adulthood and shorten people’s lives. So we’re really concerned about that.

But on the other hand, we’re also concerned about the mental illness that can also shorten and impair people’s lives. So we need to weigh the risk of the medication against the risk of the illness. But how can we reduce the risk of weight gain with antipsychotics?