Clinical trialNCT03522168CompletedObservational

Long-term Antipsychotic Pediatric Safety Trial

SponsorDuke UniversityEnrollment509Weight, Body

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - \<18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality. An additional sub-study (registry sub-study) was added via a protocol amendment. This registry sub-study is optional for participants and only participants who participate in the main study are eligible if they were 6 to less than 18 years of age at the time of the M0 visit. Participants who consent to this registry sub-study will participate in yearly in-person visits and complete monthly assessments remotely over the course of two additional years from the time of their final visit of the main LAP01 study.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Karan Kumar, MD, MS
Duke Clinical Research Institution (DCRI)
Principal Investigator
clinicaltrials.gov ↗
Kevin Watt, MD, PhD
University of Utah
Principal Investigator
clinicaltrials.gov ↗
Linmarie Sikich, MD
Duke Clinical Research Institution (DCRI)
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

37 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Arkansas Children'S Research Institute
Little Rock, Arkansas, United States
Om Research
Lancaster, California, United States
Ucla Semel Institute
Los Angeles, California, United States
Yale Child Study Center
New Haven, Connecticut, United States
Clinical Trials Solution
Miami, Florida, United States
South Florida Behavioral Health Network
Miami, Florida, United States
Scientific Clinical Research, Inc.
North Miami, Florida, United States
Valley Healthcare System
Columbus, Georgia, United States
Iact Health
Grayson, Georgia, United States
Attalla Consultants Llc Dba Institute for Behavioral Medicine
Smyrna, Georgia, United States
Amr-Baber Research, Inc.
Naperville, Illinois, United States
Beacon Medical Group
South Bend, Indiana, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital, Lurie Center for Autism
Lexington, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Neurobehavioral Medicine Group
Bloomfield, Michigan, United States
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Child and Family Study Center
Durham, North Carolina, United States
Behavioral Health Hospital Oupatient Clinic
Greensboro, North Carolina, United States
Cone Health Outpatient Behavioral Health
Greensboro, North Carolina, United States
Carolina Partners in Mental Healthcare, Pllc
Raleigh, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Avera Mckennan University Psychiatry Associates
Sioux Falls, South Dakota, United States
Le Bonheur Children'S Hospital
Memphis, Tennessee, United States
Biobehavioral Research of Austin
Austin, Texas, United States
Cook Children'S Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Aripiprazole →Risperidone →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Jan 2019
Primary completion: 21 Nov 2023
Completion: 21 Nov 2023
Last update posted: 7 Apr 2026
Registered enrollment: 509
Registry id: NCT03522168

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.