A Study of Aripiprazole in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Study of Aripiprazole in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105196
• Other study ID #: CN138-165
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2005
• Last updated: November 7, 2013
• Start date: March 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2011
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Aripiprazole+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
• Placebo+ ADT
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Locations

Country	Name	City	State
United States	Medical College Of Georgia	Augusta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Southeast Health Consultants	Charleston	South Carolina
United States	Behavioral Health Center	Charlotte	North Carolina
United States	University Of Virginia	Charlottesville	Virginia
United States	Uptown Research Institute, Llc	Chicago	Illinois
United States	Usc School Of Medicine	Columbia	South Carolina
United States	Cns Clinical Research Group	Coral Springs	Florida
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Cunningham Clinical Research, Llc	Edwardsville	Illinois
United States	Summit Research Network	Farmington Hills	Michigan
United States	Summit Research Network	Flint	Michigan
United States	Comprehensive Neuroscience, Inc.	Hoffman Estates	Illinois
United States	Radiant Research Las Vegas	Las Vegas	Nevada
United States	Suburban Research Associates	Media	Pennsylvania
United States	Dean Foundation For Health Research & Education	Middleton	Wisconsin
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Lsu Health Sciences Center	New Orleans	Louisiana
United States	Phebe Tucker, Md	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Radiant Research, Slc	Salt Lake City	Utah
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	Carman Research	Smyrna	Georgia
United States	Vine Street Clinical Research Center	Springfield	Illinois
United States	Regions Hospital	St. Paul	Minnesota
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Clinical Research Institute	Witchita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, Carson WH, Adson D, Taylor L, Hazel J, Marcus RN. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr. 2009 Apr;14(4):197-206. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MADRS Response	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).	Baseline (Week 8) and Week 14	No
Other	Clinical Global Impression (CGI)-Improvement Response	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).	Baseline (Week 8) and Week 14	No
Other	MADRS Remission	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).	Baseline (Week 8) and Week 14	No
Primary	Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)	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.	Baseline (Week 8) and Week 14	No
Secondary	Mean Change in Sheehan Disability Scale (SDS) Mean Score	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.	Baseline (Week 8) and Week 14	No
Secondary	Mean Change in SDS Item Score (Social Life)	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.	Baseline (Week 8) and Week 14	No
Secondary	Mean Change in SDS Item Score (Family Life)	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.	Baseline (Week 8) and Week 14	No
Secondary	Mean Change in SDS Item Score (Work/School)	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.	Baseline (Week 8) and Week 14	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm