What side effects are associated with this type of intervention?

Common treatments for obesity that involve medications similar to Aripiprazole and Risperidone, which act on dopamine and serotonin receptors, often have side effects such as weight gain, metabolic changes (e.g., increased blood glucose and lipid levels), and extrapyramidal symptoms like tardive dyskinesia. Other side effects can include sedation, somnolence, and cardiovascular issues. These adverse effects are important considerations when using such medications for obesity treatment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, though none are directly similar to Aripiprazole or Risperidone in their primary mechanisms of action. Approved drugs include orlistat, which reduces fat absorption, and phentermine-topiramate, which combines a sympathomimetic amine with an anticonvulsant. Lorcaserin, a serotonin 2C receptor agonist, was also approved but later withdrawn from the market. Liraglutide, a GLP-1 receptor agonist, and naltrexone-bupropion, which combines an opioid antagonist with an antidepressant, are other notable treatments. These medications primarily target appetite regulation and metabolic processes rather than the dopamine and serotonin receptor modulation seen with antipsychotics.

What other types of research exist?

Promising alternatives to Aripiprazole and Risperidone for obesity patients include Lurasidone and Ziprasidone. Both are second-generation antipsychotics with a lower risk of weight gain and metabolic side effects. Lurasidone is known for its minimal impact on weight and metabolic parameters, while Ziprasidone has a favorable profile regarding weight gain and lipid levels.

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Atypical Antipsychotic

Risperidone vs Aripiprazole for Weight Gain in Children with Autism

Phase 4

Recruiting

Led By Angela Maxwell-Horn, M.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 17 years and younger

Naïve to atypical antipsychotics

Must not have

History of atypical antipsychotic use

18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is comparing two medicines, aripiprazole and risperidone, to see which one causes more weight gain in children with autism. The study focuses on children under 18 who have behavior problems like irritability and aggression. These medicines help by calming brain activity to improve behavior. The main goal is to find out which medicine leads to less weight gain over a few months. Aripiprazole and risperidone are both FDA-approved for treating irritability in children with autism.

Who is the study for?

This trial is for children up to 17 years old with autism spectrum disorder who have behavioral issues and haven't used atypical antipsychotics before. They must be patients at the Vanderbilt clinic.

What is being tested?

The study compares weight gain in children with autism when treated with two FDA approved medications: Risperidone and Aripiprazole, during routine clinical care.

What are the potential side effects?

Possible side effects of both Risperidone and Aripiprazole include significant weight gain, drowsiness, increased appetite, fatigue, insomnia, and potential metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 17 years old or younger.

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I have never taken atypical antipsychotics.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used medication for severe mental health issues.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

weight gain

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Treatment with RisperidoneActive Control1 Intervention

Patients prescribed Risperidone

Group II: Treatment with AripiprazoleActive Control1 Intervention

Patients prescribed Aripiprazole

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often target neurotransmitter systems, particularly dopamine and serotonin pathways, to regulate appetite and satiety. Aripiprazole, a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and an antagonist at serotonin 5-HT2A receptors, and Risperidone, an antagonist at dopamine D2 and serotonin 5-HT2A receptors, influence these pathways. By modulating these neurotransmitters, these drugs can potentially reduce food cravings and improve mood, which are critical factors in managing obesity. This understanding is essential for obesity patients as it highlights the importance of neurotransmitter regulation in effective weight management strategies.

Contrasting contribution of 5-hydroxytryptamine 1A receptor activation to neurochemical profile of novel antipsychotics: frontocortical dopamine and hippocampal serotonin release in rat brain.