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This study has been withdrawn prior to enrollment.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:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00338273
First received: June 15, 2006
Last updated: November 7, 2013
Last verified: February 2012

June 15, 2006
November 7, 2013
December 2006
November 2007   (final data collection date for primary outcome measure)
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Same as current
Complete list of historical versions of study NCT00338273 on ClinicalTrials.gov Archive Site
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)
Same as current
Not Provided
Not Provided
 
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode
The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Aripiprazole
    Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.
    Other Name: Abilify
  • Drug: Placebo
    Tablets, Oral, 0 mg, Once daily, 8 weeks.
  • Active Comparator: A1
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: A2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00338273
CN138-149
Not Provided
Not Provided
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP