A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

Bipolar Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00338273
• Other study ID #: CN138-149
• Status: Withdrawn
• Phase: Phase 3
• First received: June 15, 2006
• Last updated: November 7, 2013
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: February 2012
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Outpatients

• Must sign informed consent prior to protocol-related procedures

Exclusion Criteria:

• Women who are pregnant, trying to become pregnant, or nursing

• Significant risk of committing suicide

• Any serious unstable medical conditions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder, Major

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
• Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.

Locations

Country	Name	City	State
India	Local Institution	Ahmedabad	Gujarat
India	Local Institution	Chennai
India	Local Institution	Delhi
India	Local Institution	Hyderabad
India	Local Institution	Lucknow
India	Local Institution	Mumbai
India	Local Institution	Vishakhapatnam
United States	Local Institution	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary	Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm