Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 509 participants.
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.
Interventions
- DRUG Risperidone
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 509 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2023-11-21 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03522168
The ClinicalTrials.gov registry entry for NCT03522168 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 509 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT03522168 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.