Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: June 15, 2006
Last updated: November 7, 2013
Last verified: February 2012

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

Condition Intervention Phase
Bipolar Disorder
Drug: Aripiprazole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

Enrollment: 0
Study Start Date: December 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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:
No publications provided Identifier: NCT00338273     History of Changes
Other Study ID Numbers: CN138-149
Study First Received: June 15, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

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
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on November 27, 2014