Clinical trial

Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole

Name

210757

Description

This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.

Trial arms

Trial start

2022-02-01

Estimated PCD

2024-07-01

Trial end

2025-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Comparison of Risperidone and Aripiprazole

Comparing two FDA approved medications for treatment of irritability in autism

Arms:

Treatment with Aripiprazole, Treatment with Risperidone

Size

350

Primary endpoint

weight gain

3 months

Eligibility criteria

Inclusion Criteria: * age 17 years and younger * diagnosed with autism * have behavior problems * seen in Vanderbilt clinic * naïve to atypical antipsychotics Exclusion Criteria: * 18 years or older * history of atypical antipsychotic use * not diagnosed with autism

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either Risperidone or Aripiprazole after a clinician has chosen to start the patient on an atypical antipsychotic', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

Updated at

2024-04-30

1 organization

1 product

3 indications

Organization

Vanderbilt University Medical Center

Product

Comparison of Risperidone and Aripiprazole

Indication

Weight Gain

Indication

Autism Spectrum Disorder

Indication

Adverse Drug Reaction