# Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

> **NCT00764478** · PHASE3 · COMPLETED · sponsor: **Organon and Co** · enrollment: 367 (actual)

## Conditions studied

- Bipolar 1 Disorder

## Interventions

- **DRUG:** Asenapine
- **DRUG:** Asenapine
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00764478
- **Lead sponsor:** Organon and Co
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-04-06
- **Primary completion:** 2014-04-30
- **Final completion:** 2014-05-28
- **Target enrollment:** 367 (ACTUAL)
- **Last updated:** 2024-06-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00764478

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00764478, "Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT00764478. Licensed CC0.

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