Kids' antipsychotic weight gain tracked for years in major safety study

NCT ID NCT03522168

Completed Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Apr 09, 2026 · Last updated Jun 23, 2026 · Updated 17 times

Summary

This completed study followed 509 children aged 3 to 18 who were taking risperidone or aripiprazole for conditions like schizophrenia or bipolar disorder. Researchers measured weight changes over up to 50 months to understand long-term risks. The goal was to provide better safety information for doctors and families.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

AMR-Baber Research, Inc.

Naperville, Illinois, 60563, United States
Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States
Attalla Consultants LLC dba Institute for Behavioral Medicine

Smyrna, Georgia, 30082, United States
Avera McKennan University Psychiatry Associates

Sioux Falls, South Dakota, 57108, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Beacon Medical Group

South Bend, Indiana, 46601, United States
Behavioral Health Hospital Oupatient Clinic

Greensboro, North Carolina, 27278, United States
BioBehavioral Research of Austin

Austin, Texas, 78759, United States
Carolina Partners in Mental HealthCare, PLLC

Raleigh, North Carolina, 27609, United States
Clinical Trials Solution

Miami, Florida, 33126, United States
Cone Health Outpatient Behavioral Health

Greensboro, North Carolina, 27403, United States
Cook Children's Medical Center

Fort Worth, Texas, 76104, United States
Duke Child and Family Study Center

Durham, North Carolina, 27705, United States
Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States
IACT Health

Grayson, Georgia, 30017, United States
Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States
Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Massachusetts General Hospital, Lurie Center for Autism

Lexington, Massachusetts, 02421, United States
Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10461, United States
Neurobehavioral Medicine Group

Bloomfield, Michigan, 48302, United States
Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States
OM Research

Lancaster, California, 93594, United States
Pine Rest Christian Mental Health Services

Grand Rapids, Michigan, 49548, United States
Scientific Clinical Research, Inc.

North Miami, Florida, 33161, United States
South Florida Behavioral Health Network

Miami, Florida, 33126, United States
Southwest Autism Research & Resource Center

Phoenix, Arizona, 85006, United States
UCLA Semel Institute

Los Angeles, California, 90024, United States
University of Cincinnati

Cincinnati, Ohio, 45219-2492, United States
University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68131, United States
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
University of Virginia

Charlottesville, Virginia, 22903, United States
Valley Healthcare System

Columbus, Georgia, 31903, United States
Washington University

St Louis, Missouri, 63110, United States
Yale Child Study Center

New Haven, Connecticut, 06520, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

risperidone (Risperdal) and aripiprazole (Abilify)

What this could lead to

If successful, this study could help doctors better understand and manage long-term weight gain in children taking these antipsychotic medications.

What could go wrong

This is an observational study, not a treatment trial, so it won't directly improve health. Results may not apply to all children or medications.

Conditions

The condition(s) this trial relates to.

Body Weight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

WEIGHT, BODY