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NCT02046369 · ClinicalTrials.gov registry record · Phase 3
Lurasidone Pediatric Bipolar Study
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT02046369: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT02046369 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02046369, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study Summary
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
Primary Outcome
CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. The primary efficacy endpoint will be assessed between the placebo and treatment group.
Interventions
- DRUG Placebo
- DRUG Lurasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02046369 record still lists
NCT02046369 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02046369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02046369 about?
NCT02046369 is a clinical study titled "Lurasidone Pediatric Bipolar Study". A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
What is the current status of trial NCT02046369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2014-03. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02046369?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG).
Who is sponsoring clinical trial NCT02046369?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02046369's enrollment target sits among peer trials
350 1034th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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