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NCT03522168 · ClinicalTrials.gov registry record
Long-term Antipsychotic Pediatric Safety Trial
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 509
- Enrollment target
NCT03522168: Completed study, sponsored by Duke University.
NCT03522168 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 509 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522168 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 509 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Longitudinally, evaluate the long term pathologic weight changes associated with multi- year risperidone or aripiprazole therapy over a period of 24 months in children ages 3 -\<18 years with varying durations of prior antipsychotic drug exposure at the M0 visit. The primary analysis will focus on changes in the modified Body Mass Index (BMI) z- score in children 6 - \<18 years old from M0 visit over 24 months of follow up.
Interventions
- DRUG Risperidone
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 509 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2023-11-21 |
What the finished NCT03522168 record still lists
NCT03522168 is an observational study that tracks outcomes without assigning an intervention. The registered 509 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT03522168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03522168 about?
NCT03522168 is a clinical study titled "Long-term Antipsychotic Pediatric Safety Trial". 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 be...
What is the current status of trial NCT03522168?
This trial is currently completed. The enrollment target is 509 participants. The study started on 2019-01-10. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT03522168?
The interventions under investigation include: Risperidone (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT03522168?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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