A Study of Aripiprazole in Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Aripiprazole+ ADTDrug: Placebo+ ADT
- Registration Number
- NCT00105196
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- 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.
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.
Related Research Topics
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Trial Locations
- Locations (32)
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
Cns Clinical Research Group
🇺🇸Coral Springs, Florida, United States
Medical College Of Georgia
🇺🇸Augusta, Georgia, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Uptown Research Institute, Llc
🇺🇸Chicago, Illinois, United States
Cunningham Clinical Research, Llc
🇺🇸Edwardsville, Illinois, United States
Comprehensive Neuroscience, Inc.
🇺🇸Hoffman Estates, Illinois, United States
Vine Street Clinical Research Center
🇺🇸Springfield, Illinois, United States
Scroll for more (22 remaining)University Of Alabama At Birmingham🇺🇸Birmingham, Alabama, United States