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

NCT ID NCT03522168

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

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

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.

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.

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.

Participants

509 people

The number who actually took part.

Started

Jan 2019

Finished

Nov 2023

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.

Who is studied

Main Study: The study population will consist of two groups of children 3 - \<18 yrs old at the M0 visit: * Risperidone group, n=350, including 30 children 3 - \<6 yrs old and 320 children 6 - \<18 yrs old, \~ 50% - 80% will have \<90 days of prior treatment with any antipsychotic. * Aripiprazole group, n=350, including 30 children 3 - \<6 yrs old and 320 children 6 - \<18 yrs old., \~ 50% - 80% will have ≤90 days of prior treatment with any antipsychotic. We will target participants within each treatment group to be distributed across the age range to permit analyses of age effects with: * \~30 being 3 - \<6 years * ≥35% (n ≥123) being 6 - \<12 years * ≥35% (n ≥123) being 12 - \<18 years PK sub group at selected sites includes 24 participates, details in protocol. Registry Sub-Study Registry participants will be selected exclusively from the population that has enrolled onto the LAPS Trial.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Main Study Inclusion Criteria: 1. Parent/guardian has provided informed consent 2. Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB) 3. 3 - \<18 years of age inclusive at time of M0 visit 4. Participant, when developmentally appropriate, and parent/guardian are: 1. Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider 2. Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP 5. Based on their age at the time of M0 visit, participant is receiving aripiprazole or risperidone at the dose and for the diagnoses as listed below: 1. Participants ages 3 - \< 6 years can have any diagnosis and any dose 2. Participants ages ≥ 6 - \<18 years at the doses and for the diagnoses listed below Labeled Indications (Closely Related Disorders) Aripiprazole 2-30 mg/day * Irritability associated with autistic disorder: (Irritability in autism spectrum disorder) - Treatment of Tourette's disorder: (Tourette's disorder, persistent (chronic) motor or vocal tic disorder) \- Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar l disorder: (Bipolar spectrum disorders including disruptive mood dysregulation disorder) \- Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder) Risperidone 0.25-6 mg/day - Irritability associated with autistic disorder: (Irritability in autism spectrum disorder) \- Bipolar Mania: (Bipolar spectrum disorders including disruptive mood dysregulation disorder) \- Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder) * MYCITE® (aripiprazole) and all forms of injectables are not permitted in this study 6. Guardian anticipates risperidone or aripiprazole treatment will continue for ≥6 months Exclusion Criteria: 1. History of prior or current diagnosis of an eating disorder or meets diagnostic criteria for an eating disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and determined by psychiatric exam 2. Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems 3. Known or self-reported pregnancy 4. Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit 5. Contraindications to participation in the study in the opinion of the SMC 6. Unwilling or unable to provide back-up family contact information Registry Sub-Study Inclusion Criteria: 1. Enrolled in LAPS Trial 2. Access to a personal mobile device (with Bluetooth capability and data or internet access) and willing to use it for the purposes of this study 3. Parent/guardian/LAR/participant has provided informed consent 4. Participant has provided assent/consent if developmentally appropriate and as required by the institutional review board (IRB) 5. Participant was part of the 6 to \<18 year-old group in the LAPS Trial Exclusion Criteria: 1\. Participant has completed the M24 LAPS Trial Visit

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Conditions

The condition(s) this trial relates to.

autism bipolar I disorder Body Weight schizophrenia Tourette syndrome

As listed by the trial registrant

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

Weight, body

Contacts and locations

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

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