# Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)

> **NCT01244815** · PHASE3 · COMPLETED · sponsor: **Organon and Co** · enrollment: 404 (actual)

## Conditions studied

- Bipolar Disorder, Pediatric

## Interventions

- **DRUG:** asenapine
- **DRUG:** Placebo to match asenapine
- **DRUG:** Rescue medication

## Key facts

- **NCT ID:** NCT01244815
- **Lead sponsor:** Organon and Co
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-06-16
- **Primary completion:** 2013-08-28
- **Final completion:** 2013-09-17
- **Target enrollment:** 404 (ACTUAL)
- **Last updated:** 2024-06-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01244815

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01244815, "Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT01244815. Licensed CC0.

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