# Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder

> **NCT00665366** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 493 (actual)

## Conditions studied

- Bipolar Disorder Mania

## Interventions

- **DRUG:** Aripiprazole
- **DRUG:** Placebo
- **DRUG:** Lithium
- **DRUG:** Valproate

## Key facts

- **NCT ID:** NCT00665366
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2008-06
- **Primary completion:** 2011-10
- **Final completion:** 2011-10
- **Target enrollment:** 493 (ACTUAL)
- **Last updated:** 2013-12-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00665366

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00665366, "Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00665366. Licensed CC0.

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