A Study of Aripiprazole in Patients With Major Depressive Disorder

• Mean Change in Sheehan Disability Scale (SDS) Mean Score [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
  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 (Social Life) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
  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 SDS Item Score (Family Life) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
  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.
• Mean Change in SDS Item Score (Work/School) [ Time Frame: Baseline (Week 8) and Week 14 ] [ Designated as safety issue: No ]
  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.

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.

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

• Experimental: A1
  Intervention: Drug: Aripiprazole+ ADT
• Placebo Comparator: A2
  Intervention: Drug: Placebo+ ADT

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.