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Which autism drug causes less weight gain? small study aims to find out

NCT ID NCT04903353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

autism spectrum disorder Drug-Related Side Effects and Adverse Reactions Weight Gain

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.