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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00338273
First received: June 15, 2006
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338273

Locations
United States, North Carolina
Local Institution
Durham, North Carolina, United States
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, India
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00338273     History of Changes
Other Study ID Numbers: CN138-149
Study First Received: June 15, 2006
Last Updated: February 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Bipolar I disorder with major depressive episode

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013