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J Affect Disord. 2014 Jun;162:20-5. doi: 10.1016/j.jad.2014.03.017. Epub 2014 Mar 24.

Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis.

Author information

  • 1Yale School of Medicine, New Haven, CT, USA.
  • 2Otsuka America Pharmaceutical, Inc., Princeton, NJ, USA.
  • 3Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ, USA.
  • 4Bristol-Myers Squibb, Plainsboro, NJ, USA.
  • 5Bristol-Myers Squibb, Wallingford, CT, USA.
  • 6Yale School of Medicine, New Haven, CT, USA; Bristol-Myers Squibb, Wallingford, CT, USA.
  • 7Department of Psychiatry, University of California, San Francisco, 401 Parnassus Avenue, San Francisco, CA 94143, USA. Electronic address: CraigN@lppi.ucsf.edu.

Abstract

BACKGROUND:

There is a paucity of evidence for outcome predictors in patients with major depressive disorder (MDD) not responding to initial antidepressant therapy (ADT). This post-hoc analysis evaluated whether MDD severity affects response to adjunctive aripiprazole.

METHODS:

Data from 3 randomized, double-blind, placebo-controlled trials of adjunctive aripiprazole in adults with MDD and inadequate response to 1 to 3 ADT trials were pooled and stratified based on Montgomery-Åsberg Depression Rating Scale (MADRS) total score (mild, ≤24; moderate, 25-30; severe, ≥31). Treatment differences in change in MADRS total score and rates of response (≥50% MADRS improvement) and remission (response with MADRS total score ≤10) were analyzed at endpoint. Adverse events were assessed within each subgroup.

RESULTS:

Aripiprazole produced greater improvement than placebo in the MADRS total score regardless of MDD severity at baseline (between-treatment difference [95% CI]: mild, -2.5 [-4.0 to -1.1]; moderate, -3.2 [-4.9 to -1.6]; severe, -4.5 [-6.8 to -2.2]). Compared with placebo, adjunctive aripiprazole increased the likelihood of response in all subgroups (risk ratio [95% CI]: mild, 1.50 [1.15, 1.95]; moderate, 1.51 [1.09, 2.11]; severe, 1.95 [1.23, 3.10]). Common treatment-emergent adverse events included akathisia and restlessness.

LIMITATIONS:

The original studies were not designed to assess the efficacy of adjunctive aripiprazole by baseline severity, and this post-hoc analysis was not powered to evaluate differences in severity subgroups.

CONCLUSIONS:

In patients who failed to respond to initial ADT, adjunctive aripiprazole was more effective than placebo in mild, moderate, and severe MDD strata.

CLINICAL TRIAL REGISTRATION:

ClinicalTrial.gov: NCT00095823, NCT00105196, and NCT00095758.

Copyright © 2014. Published by Elsevier B.V.

KEYWORDS:

Antidepressant therapy; Augmentation; Major depressive disorder; Symptom severity

PMID:
24766999
[PubMed - indexed for MEDLINE]
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