Clinical Trials Directory

Trials / Completed

CompletedNCT00606281

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
258 (actual)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.

Conditions

Interventions

TypeNameDescription
DRUGAripiprazoleoral, 24mg/day
DRUGplacebooral, 0mg(4tablets)/day

Timeline

Start date
2008-01-01
Primary completion
2010-11-01
Completion
2010-11-01
First posted
2008-02-01
Last updated
2014-02-12
Results posted
2014-02-12

Locations

12 sites across 4 countries: China, Japan, South Korea, Taiwan

Source: ClinicalTrials.gov record NCT00606281. Inclusion in this directory is not an endorsement.