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This study has been withdrawn prior to enrollment.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
Mean change from baseline to endpoint (Week 8 Last Observation Carried Forward =LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score
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Withdrawn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
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00338273
CN138-149
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