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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00338273
Recruitment Status : Withdrawn
First Posted : June 20, 2006
Last Update Posted : November 8, 2013
Information provided by:

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Aripiprazole Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A1 Drug: Aripiprazole
Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
Other Name: Abilify
Placebo Comparator: A2 Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 8 weeks.

Outcome Measures

Primary Outcome Measures :
  1. Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures :
  1. Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338273

United States, North Carolina
Local Institution
Durham, North Carolina, United States
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, India
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00338273     History of Changes
Other Study ID Numbers: CN138-149
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: February 2012

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar I disorder with major depressive episode

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs