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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Aripiprazole+ ADT
Drug: Placebo+ ADT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Study of Aripiprazole in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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).


Enrollment: 349
Study Start Date: March 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Aripiprazole+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
Other Name: Abilify
Placebo Comparator: A2 Drug: Placebo+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105196

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35205
United States, California
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Cns Clinical Research Group
Coral Springs, Florida, United States, 33065
United States, Georgia
Medical College Of Georgia
Augusta, Georgia, United States, 30912
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Uptown Research Institute, Llc
Chicago, Illinois, United States, 60640
Cunningham Clinical Research, Llc
Edwardsville, Illinois, United States, 62025
Comprehensive Neuroscience, Inc.
Hoffman Estates, Illinois, United States, 60194
Vine Street Clinical Research Center
Springfield, Illinois, United States, 62711
United States, Kansas
Clinical Research Institute
Witchita, Kansas, United States, 67211
United States, Louisiana
Lsu Health Sciences Center
New Orleans, Louisiana, United States, 70115
United States, Maryland
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
United States, Michigan
Summit Research Network
Farmington Hills, Michigan, United States, 48336
Summit Research Network
Flint, Michigan, United States, 48507
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55454
Regions Hospital
St. Paul, Minnesota, United States, 55101
United States, Nevada
Radiant Research Las Vegas
Las Vegas, Nevada, United States, 89146
United States, North Carolina
Behavioral Health Center
Charlotte, North Carolina, United States, 28211
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Oklahoma
Phebe Tucker, Md
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Summit Research Network
Portland, Oregon, United States, 97210
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Southeast Health Consultants
Charleston, South Carolina, United States, 29407
Usc School Of Medicine
Columbia, South Carolina, United States, 29203
United States, Texas
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
United States, Utah
Radiant Research, Slc
Salt Lake City, Utah, United States, 84107
University Of Utah School Of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
University Of Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
Northbrooke Research Center
Brown Deer, Wisconsin, United States, 53223
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00105196     History of Changes
Other Study ID Numbers: CN138-165
Study First Received: March 9, 2005
Results First Received: March 27, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Single or recurrent
non-psychotic episode of Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
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 September 22, 2014