Which autism drug causes less weight gain? small study aims to find out
NCT ID NCT04903353
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study compared two FDA-approved medications, risperidone and aripiprazole, used to treat irritability in children with autism. The goal was to see which one causes more weight gain. Thirty children under 18 who had never taken these drugs before were followed during routine care. Results could help doctors choose the better option for managing behavior problems with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- risperidone and aripiprazole
- What this could lead to
- If this trial succeeds, it could help doctors choose which medication causes less weight gain in children with autism.
- What could go wrong
- This is a small, completed Phase 4 trial with only 30 children, so results may not apply to all kids. Weight gain is a known side effect of both drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
30 people
The number who actually took part.
- Started
-
Feb 2022
- Finished
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Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 17 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Division of Developmental Medicine
Nashville, Tennessee, 37212, United States
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Other studies related to the condition(s) this trial covers.
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