A Study of Aripiprazole in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Study of Aripiprazole in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Aripiprazole+ ADT
* Drug: Placebo+ ADT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Aripiprazole+ ADT<br>* Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks<br>* Other names: Abilify;|
| Placebo Comparator: A2<br> | Drug: Placebo+ ADT<br>* Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single or recurrent, non-psychotic episode of Major Depressive Disorder