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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:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00105196
First received: March 9, 2005
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  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:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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.


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

  Show 34 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Study Director, Bristol-Myers Squibb
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: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Single or recurrent
non-psychotic episode of Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
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 May 22, 2013