Major Depressive Disorder Clinical Trial
Official title:
A Study of Aripiprazole in Patients With Major Depressive Disorder
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
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 |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical |
United States,
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
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 |
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