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NCT01396291 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 561
- Enrollment target
NCT01396291: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01396291 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 561 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396291, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 561 participants
- Enrollment target
Study Summary
This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-label asenapine and matching placebo for 12 to 16 weeks. Participants who meet stabilization criteria may then be randomized into one of the two study arms (asenapine or matching placebo) to receive double-blind treatment for up to an additional 26-weeks.
Interventions
- DRUG placebo
- DRUG asenapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 561 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT01396291 record still lists
NCT01396291 is an interventional study that assigns participants to a tested intervention. The registered 561 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 (27% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01396291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01396291 about?
NCT01396291 is a clinical study titled "Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)". This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1 Disorder. After a Screening Period, each participant will receive open-lab...
What is the current status of trial NCT01396291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 561 participants. The study started on 2011-12. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01396291?
The interventions under investigation include: placebo (DRUG), asenapine (DRUG).
Who is sponsoring clinical trial NCT01396291?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01396291's enrollment target sits among peer trials
561 670th of 2000 higher than 1,330 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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