# Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)

> **NCT01396291** · PHASE3 · COMPLETED · sponsor: **Forest Laboratories** · enrollment: 561 (actual)

## Conditions studied

- Bipolar 1 Disorder

## Interventions

- **DRUG:** asenapine
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT01396291
- **Lead sponsor:** Forest Laboratories
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-12
- **Primary completion:** 2015-04
- **Final completion:** 2015-06
- **Target enrollment:** 561 (ACTUAL)
- **Last updated:** 2015-12-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01396291

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01396291, "Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)". Retrieved via AI Analytics 2026-06-15 from https://api.ai-analytics.org/clinical/NCT01396291. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
