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Trial record 58 of 1951 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Major Depressive Disorder

A Study of Aripiprazole in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00105196
Recruitment Status : Completed
First Posted : March 10, 2005
Results First Posted : May 18, 2009
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE March 9, 2005
First Posted Date  ICMJE March 10, 2005
Results First Submitted Date  ICMJE March 27, 2009
Results First Posted Date  ICMJE May 18, 2009
Last Update Posted Date December 2, 2013
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2011)
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (Week 8) and Week 14 ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00105196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2011)
  • Mean Change in Sheehan Disability Scale (SDS) Mean Score [ Time Frame: Baseline (Week 8) and Week 14 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 7, 2013)
  • MADRS Response [ Time Frame: Baseline (Week 8) and Week 14 ]
    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 ]
    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 ]
    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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Aripiprazole in Patients With Major Depressive Disorder
Official Title  ICMJE A Study of Aripiprazole in Patients With Major Depressive Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A1
    Intervention: Drug: Aripiprazole+ ADT
  • Placebo Comparator: A2
    Intervention: Drug: Placebo+ ADT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
349
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00105196
Other Study ID Numbers  ICMJE CN138-165
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Otsuka America Pharmaceutical
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date April 2011

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