Risperidone vs Aripiprazole for Weight Gain in Children with Autism

Overseen By Sally Furukawa

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanderbilt University Medical Center

Must not be taking: Atypical antipsychotics

Disqualifiers: Age 18+, No autism diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 months

350 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you must not have used atypical antipsychotics before.

What data supports the effectiveness of the drugs Risperidone and Aripiprazole for weight gain in children with autism?

Research shows that both Risperidone and Aripiprazole are effective in reducing irritability and aggression in children with autism, and they also improve core autism symptoms. However, they can lead to weight gain, which is a common side effect observed in some children. ^{1 2 3 4 5}

Is it safe for children with autism to use risperidone or aripiprazole?

Risperidone and aripiprazole are generally considered safe for children with autism, but they can cause significant weight gain and metabolic issues. In some studies, excessive weight gain was the only side effect that required intervention. ^{1 2 3 5 6}

How do risperidone and aripiprazole differ from other drugs for autism in children?

Risperidone and aripiprazole are unique because they are the only FDA-approved drugs specifically for treating irritability in children with autism, and they have shown potential in improving core autism symptoms when combined with supportive therapies. Unlike other treatments, they have been studied for their effects on weight gain, which is a common concern in children with autism. ^{1 2 3 4 5}

Research Team

Angela Maxwell-Horn, M.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am 17 years old or younger.

I have never taken atypical antipsychotics.

Diagnosed with autism

Exclusion Criteria

Not diagnosed with autism

I have used medication for severe mental health issues.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either aripiprazole or risperidone for the treatment of behavioral dysregulation

3 months

Follow-up

Participants are monitored for weight gain at a follow-up visit

3 months

1 visit (in-person)

Treatment Details

Interventions

• Aripiprazole
• Risperidone

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

Participant Groups

Group I: Treatment with Risperidone Active Control 1 Intervention

Patients prescribed Risperidone

Group II: Treatment with Aripiprazole Active Control 1 Intervention

Patients prescribed Aripiprazole

Aripiprazole is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Abilify for:

• Irritability associated with autism spectrum disorder in children aged 6 to 17

Approved in European Union as Abilify for:

• Schizophrenia
• Bipolar I disorder
• Major depressive disorder
• Irritability associated with autistic disorder

Approved in Canada as Abilify for:

• Schizophrenia
• Bipolar I disorder
• Major depressive disorder
• Irritability associated with autistic disorder

Approved in Japan as Abilify for:

• Schizophrenia
• Bipolar disorder
• Major depressive disorder
• Irritability associated with pervasive developmental disorders

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

Both risperidone and aripiprazole are effective in reducing the severity of autism symptoms, including repetitive behaviors and social withdrawal, based on an overview of 22 systematic reviews involving children aged 12 years or younger.

While these medications show moderate efficacy in the short term, they are also associated with potential metabolic and neurological side effects, highlighting the need for careful monitoring and further research with longer follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risperidone and aripiprazole for autism spectrum disorder in children: an overview of systematic reviews. Fieiras, C., Chen, MH., Escobar Liquitay, CM., et al.[2023]

In a study of 142 children and young adults with autism spectrum disorders treated with risperidone or aripiprazole, both medications led to significant increases in body mass index (BMI) and BMI Z-scores over time.

There was no significant difference in the rate of BMI or BMI Z-score change between the two treatment groups, indicating that both medications have similar effects on weight gain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body mass index change in autism spectrum disorders: comparison of treatment with risperidone and aripiprazole. Wink, LK., Early, M., Schaefer, T., et al.[2021]

In a study of 82 children aged 2 to 13 with autism spectrum disorder (ASD), treatment with risperidone or aripiprazole led to significant improvements in challenging behaviors, with 96% of patients showing notable improvement according to the Clinical Global Impression scale.

While the medications were effective, some side effects were noted, including elevated prolactin levels in 12 patients and weight gain in 2 patients, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core Signs and Symptoms in Children with Autism Spectrum Disorder Improved after Starting Risperidone and Aripiprazole in Combination with Standard Supportive Therapies: A Large, Single-Center, Retrospective Case Series. Alsayouf, HA., Talo, H., Biddappa, ML.[2023]

In a clinical trial involving 59 children and adolescents with autism spectrum disorders, both aripiprazole and risperidone were effective in reducing irritability, as measured by the Aberrant Behavior Checklist (ABC) scores over 2 months.

The study found that the rates of adverse effects were similar for both medications, indicating that aripiprazole (mean dose 5.5 mg/day) and risperidone (mean dose 1.12 mg/day) have comparable safety profiles, allowing treatment choice to be based on patient preference and clinical considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. Ghanizadeh, A., Sahraeizadeh, A., Berk, M.[2022]

In a retrospective case study of 10 children under 4 years old with autism spectrum disorder (ASD), treatment with risperidone or aripiprazole led to significant improvements in both irritability and core ASD symptoms, with 60% of patients showing minimal-to-no symptoms after treatment.

The only notable adverse effect was excessive weight gain in two patients, highlighting the need for careful monitoring, but overall, the findings suggest that pharmacological intervention may be beneficial for very young children with ASD, warranting further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risperidone or Aripiprazole Can Resolve Autism Core Signs and Symptoms in Young Children: Case Study. Alsayouf, HA., Talo, H., Biddappa, ML., et al.[2021]

The SPACe 2: STAR study is a randomized controlled trial involving 140 children aged 6 to 18, aimed at determining if therapeutic drug monitoring (TDM) of antipsychotics like risperidone and aripiprazole can prevent significant weight gain while maintaining treatment effectiveness for autism-related behavioral issues.

This study will be the first of its kind to evaluate the impact of TDM on weight management and metabolic side effects in children taking antipsychotics, with primary outcomes measured by BMI z-scores at 24 weeks, providing crucial insights for optimizing treatment in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of therapeutic drug monitoring of risperidone and aripiprazole on weight gain in children and adolescents: the SPACe 2: STAR (trial) protocol of an international multicentre randomised controlled trial. Hermans, RA., Ringeling, LT., Liang, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Risperidone and aripiprazole for autism spectrum disorder in children: an overview of systematic reviews. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Body mass index change in autism spectrum disorders: comparison of treatment with risperidone and aripiprazole. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Core Signs and Symptoms in Children with Autism Spectrum Disorder Improved after Starting Risperidone and Aripiprazole in Combination with Standard Supportive Therapies: A Large, Single-Center, Retrospective Case Series. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A head-to-head comparison of aripiprazole and risperidone for safety and treating autistic disorders, a randomized double blind clinical trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Risperidone or Aripiprazole Can Resolve Autism Core Signs and Symptoms in Young Children: Case Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The effect of therapeutic drug monitoring of risperidone and aripiprazole on weight gain in children and adolescents: the SPACe 2: STAR (trial) protocol of an international multicentre randomised controlled trial. [2022]