Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 561 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01396291
The ClinicalTrials.gov registry entry for NCT01396291 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 561 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01396291 reports 0 study locations.
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
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.