Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
Public ClinicalTrials.gov record NCT01396291. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01396291
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 561 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2011 (Type not available)
- Primary completion
- Apr 2015 (Actual)
- Completion
- Jun 2015 (Actual)
- Last update posted
- Dec 4, 2015
2011 – 2015
United States locations
- U.S. sites
- 30
- U.S. states
- 13
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 3017 | Anaheim | California | 92805 | — |
| Forest Investigative Site 3019 | Chino | California | 91710 | — |
| Forest Investigative Site 3001 | Escondido | California | 92025 | — |
| Forest Investigative Site 3004 | National City | California | 91950 | — |
| Forest Investigative Site 3006 | Oakland | California | 94612 | — |
| Forest Investigative Site 3003 | Orange | California | 92868 | — |
| Forest Investigative Site 3007 | Torrance | California | 90502 | — |
| Forest Investigative Site 3042 | Colorado Springs | Colorado | 80910 | — |
| Forest Investigative Site 3012 | Jacksonville | Florida | 32256 | — |
| Forest Investigative Site 3040 | Kissimmee | Florida | 34741 | — |
| Forest Investigative Site 3031 | Leesburg | Florida | 34748 | — |
| Forest Investigative Site 3015 | Miami | Florida | 33126 | — |
| Forest Investigative Site 3010 | Tampa | Florida | 33613 | — |
| Forest Investigative Site 3039 | Atlanta | Georgia | 30331 | — |
| Forest Investigative Site 3032 | Chicago | Illinois | 60640 | — |
| Forest Investigative Site 3029 | Schaumburg | Illinois | 60194 | — |
| Forest Investigative Site 3021 | Witchita | Kansas | 67207 | — |
| Forest Investigative Site 3014 | Gladstone | Missouri | 64118 | — |
| Forest Investigative Site 3002 | Albuquerque | New Mexico | 87108 | — |
| Forest Investigative Site 3024 | Elmsford | New York | 10523 | — |
| Forest Investigative Site 3037 | Avon Lake | Ohio | 44012 | — |
| Forest Investigative Site 3041 | Cincinnati | Ohio | 45219 | — |
| Forest Investigative Site 3023 | Oklahoma City | Oklahoma | 73112 | — |
| Forest Investigative Site 3035 | Oklahoma City | Oklahoma | 73116 | — |
| Forest Investigative Site 3033 | Memphis | Tennessee | 38119 | — |
| Forest Investigative Site 3009 | Houston | Texas | 77030 | — |
| Forest Investigative Site 3020 | Houston | Texas | 77090 | — |
| Forest Investigative Site 3036 | Irving | Texas | 75062 | — |
| Forest Investigative Site 3027 | Plano | Texas | 75093 | — |
| Forest Investigative Site 3000 | Wichita Falls | Texas | 76309 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 50 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01396291, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2015 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01396291 live on ClinicalTrials.gov.