Long-term Antipsychotic Pediatric Safety Trial
Completed
Conditions studied: Weight, Body
In brief
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.
Key facts
- Study ID
- NCT03522168
- Run by
- Duke University
- People needed
- 509
- Starts
- 2019-01-10
- Expected to finish
- 2023-11-21
- Last updated by the study team
- 2026-04-07
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parent/guardian has provided informed consent
- Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB)
- 3 - <18 years of age inclusive at time of M0 visit
- Participant, when developmentally appropriate, and parent/guardian are:
- Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider
- Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP
- 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:
- Participants ages 3 - < 6 years can have any diagnosis and any dose
- 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
- Guardian anticipates risperidone or aripiprazole treatment will continue for ≥6 months
You may not qualify if…
- 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
- Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems
- Known or self-reported pregnancy
- Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit
- Contraindications to participation in the study in the opinion of the SMC
- Unwilling or unable to provide back-up family contact information
- Registry Sub-Study
- Inclusion Criteria:
- Enrolled in LAPS Trial
- 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
- Parent/guardian/LAR/participant has provided informed consent
- Participant has provided assent/consent if developmentally appropriate and as required by the institutional review board (IRB)
- Participant was part of the 6 to <18 year-old group in the LAPS Trial
- Exclusion Criteria:
- Participant has completed the M24 LAPS Trial Visit
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.