title: Improvement in functional outcomes with adjunctive aripiprazole versus placebo in major depressive disorder: a pooled post hoc analysis of 3 short-term studies.
abstract: OBJECTIVE
  To evaluate the effect of adjunctive aripiprazole to antidepressant therapy (ADT) on functional outcomes, as assessed by the Sheehan Disability Scale (SDS).
  
  
  METHODS
  A post hoc analysis of pooled data from 3 similarly designed randomized, placebo-controlled trials was conducted (CN138-139 [September 2004-December 2006], CN138-163 [June 2004-April 2006], and CN138-165 [March 2005-April 2008]). Patients with DSM-IV major depressive disorder who had a prior inadequate response to ADT received adjunctive aripiprazole or placebo to standard ADT. The change from baseline to endpoint on total SDS score and on individual SDS domains and the distributional categorical shifts of patient-reported severity of functional impairment on the SDS were assessed.
  
  
  RESULTS
  Aripiprazole compared to placebo augmentation produced significant improvements in self-reported functioning levels in the SDS mean total score (-1.2 vs -0.7, P ≤ .001) and social life (-1.4 vs -0.7, P ≤ .001) and family life (-1.4 vs -0.7, P ≤ .001) domains. Additionally, a significant number of patients exhibited a shift from a severe/moderate level of impairment at baseline to a mild level of functional impairment after 6 weeks of adjunctive aripiprazole treatment compared with placebo in the SDS mean total score (P = .001) and social life (P ≤ .001) and family life (P = .001) scores.
  
  
  CONCLUSIONS
  Aripiprazole augmentation of standard antidepressant therapy resulted in significant improvements in both total and individual domains of functioning, as assessed by the SDS, with significant categorical shifts from severe/moderate to mild levels of functioning compared with placebo augmentation.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT00095823, NCT00095758, and NCT00105196.
authors.affiliation: Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania (Dr Fabian and Ms Tang); Bristol-Myers Squibb Co, Plainsboro, New Jersey (Drs Cain, Ammerman, and Berman and Mr Eudicone); Bristol-Myers Squibb Co, Wallingford, Connecticut (Dr Rollin); and Otsuka Pharmaceutical Development and Commercialization, Inc, Princeton, New Jersey (Drs Forbes and Baker).
authors.forename: Tanya J
authors.initials: TJ
authors.lastname: Fabian
authors.forename: Zachary J
authors.initials: ZJ
authors.lastname: Cain
authors.forename: Diane
authors.initials: D
authors.lastname: Ammerman
authors.forename: James M
authors.initials: JM
authors.lastname: Eudicone
authors.forename: Yan
authors.initials: Y
authors.lastname: Tang
authors.forename: Linda M
authors.initials: LM
authors.lastname: Rollin
authors.forename: Robert A
authors.initials: RA
authors.lastname: Forbes
authors.forename: Robert M
authors.initials: RM
authors.lastname: Berman
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker