A Study of Aripiprazole in Patients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Aripiprazole+ ADT; Drug: Placebo+ ADT

• Registration Number: NCT00105196
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-03-09
• Study First Submitted QC: 2005-03-09
• Study First Posted: 2005-03-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-27
• Results First Submitted QC: 2009-03-27
• Results First Posted: 2009-05-18
• Status Verified: 2011-04
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	Aripiprazole+ ADT	-
A2	Placebo+ ADT	-

Primary Outcome Measures

Name	Time	Method
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in SDS Item Score (Social Life)	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 Sheehan Disability Scale (SDS) Mean Score	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 (Work/School)	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.
Mean Change in SDS Item Score (Family Life)	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.

Trial Locations

Locations (32)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Clinical Research Institute; 🇺🇸 Witchita, Kansas, United States

Uptown Research Institute, Llc; 🇺🇸 Chicago, Illinois, United States

Usc School Of Medicine; 🇺🇸 Columbia, South Carolina, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Carman Research; 🇺🇸 Smyrna, Georgia, United States

Comprehensive Neuroscience, Inc.; 🇺🇸 Hoffman Estates, Illinois, United States

Vine Street Clinical Research Center; 🇺🇸 Springfield, Illinois, United States

Community Clinical Research, Inc.; 🇺🇸 Austin, Texas, United States

Medical College Of Georgia; 🇺🇸 Augusta, Georgia, United States

University Of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Summit Research Network; 🇺🇸 Portland, Oregon, United States

University Of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

University Of Utah School Of Medicine; 🇺🇸 Salt Lake City, Utah, United States

Sharp Mesa Vista Hospital; 🇺🇸 San Diego, California, United States

Phebe Tucker, Md; 🇺🇸 Oklahoma City, Oklahoma, United States

Radiant Research, Slc; 🇺🇸 Salt Lake City, Utah, United States

Suburban Research Associates; 🇺🇸 Media, Pennsylvania, United States

Cns Clinical Research Group; 🇺🇸 Coral Springs, Florida, United States

Cunningham Clinical Research, Llc; 🇺🇸 Edwardsville, Illinois, United States

Behavioral Health Center; 🇺🇸 Charlotte, North Carolina, United States

Regions Hospital; 🇺🇸 St. Paul, Minnesota, United States

Lsu Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Southeast Health Consultants; 🇺🇸 Charleston, South Carolina, United States

Dean Foundation For Health Research & Education; 🇺🇸 Middleton, Wisconsin, United States

Pharmasite Research, Inc.; 🇺🇸 Baltimore, Maryland, United States

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

University Of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University Of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Radiant Research Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Northbrooke Research Center; 🇺🇸 Brown Deer, Wisconsin, United States