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NCT01731119 · ClinicalTrials.gov registry record · Phase 2
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01731119 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 9 participants.
The verdict
NCT01731119, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.
Interventions
- DRUG Latuda©
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01731119
The ClinicalTrials.gov registry entry for NCT01731119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Latuda© is the first listed.
NCT01731119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01731119 about?
NCT01731119 is a clinical study titled "Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents". The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale tri...
What is the current status of trial NCT01731119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2012-12. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01731119?
The interventions under investigation include: Latuda© (DRUG).
Who is sponsoring clinical trial NCT01731119?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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