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A Study of Aripiprazole in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00105196
First received: March 9, 2005
Last updated: November 7, 2013
Last verified: April 2011

March 9, 2005
November 7, 2013
March 2005
March 2008   (final data collection date for primary outcome measure)
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Not Provided
Complete list of historical versions of study NCT00105196 on ClinicalTrials.gov Archive Site
  • Mean Change in Sheehan Disability Scale (SDS) Mean Score [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
  • Mean Change in SDS Item Score (Social Life) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
  • Mean Change in SDS Item Score (Family Life) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
  • Mean Change in SDS Item Score (Work/School) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Not Provided
  • MADRS Response [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).
  • Clinical Global Impression (CGI)-Improvement Response [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).
  • MADRS Remission [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
    Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).
Not Provided
 
A Study of Aripiprazole in Patients With Major Depressive Disorder
A Study of Aripiprazole in Patients With Major Depressive Disorder

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Major Depressive Disorder
  • Drug: Aripiprazole+ ADT
    Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
    Other Name: Abilify
  • Drug: Placebo+ ADT
    Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
  • Experimental: A1
    Intervention: Drug: Aripiprazole+ ADT
  • Placebo Comparator: A2
    Intervention: Drug: Placebo+ ADT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
349
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
  • Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105196
CN138-165
No
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
April 2011

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