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Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis.
- Source :
-
Journal of affective disorders [J Affect Disord] 2014 Jun; Vol. 162, pp. 20-5. Date of Electronic Publication: 2014 Mar 24. - Publication Year :
- 2014
-
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.<br />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.<br />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.<br />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.<br />Conclusions: In patients who failed to respond to initial ADT, adjunctive aripiprazole was more effective than placebo in mild, moderate, and severe MDD strata.<br />Clinical Trial Registration: ClinicalTrial.gov: NCT00095823, NCT00105196, and NCT00095758.<br /> (Copyright © 2014. Published by Elsevier B.V.)
- Subjects :
- Adolescent
Adult
Aged
Aripiprazole
Depressive Disorder, Major diagnosis
Depressive Disorder, Major physiopathology
Double-Blind Method
Female
Humans
Male
Middle Aged
Odds Ratio
Piperazines adverse effects
Psychomotor Agitation etiology
Quinolones adverse effects
Antidepressive Agents therapeutic use
Depressive Disorder, Major drug therapy
Piperazines therapeutic use
Quinolones therapeutic use
Severity of Illness Index
Subjects
Details
- Language :
- English
- ISSN :
- 1573-2517
- Volume :
- 162
- Database :
- MEDLINE
- Journal :
- Journal of affective disorders
- Publication Type :
- Academic Journal
- Accession number :
- 24766999
- Full Text :
- https://doi.org/10.1016/j.jad.2014.03.017