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Effects of Adjunctive Aripiprazole on Sexual Functioning in Patients With Major Depressive Disorder and an Inadequate Response to Standard Antidepressant Monotherapy: A Post Hoc Analysis of 3 Randomized, Double-Blind, Placebo-Controlled Studies

Prim Care Companion CNS Disord 2011;13(1):e1-e10

Objective: To investigate the specific effect of adjunctive aripiprazole on sexual function in patients with major depressive disorder and a history of an inadequate response to antidepressant medication by controlling for improvement in depressive symptoms as measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total scores.

Method: For this post hoc analysis, data were pooled from 3 multicenter, randomized, double-blind, placebo-controlled aripiprazole augmentation studies (CN138-139: June 2004–April 2006; CN138-163: September 2004–December 2006; and CN138-165: March 2005–April 2008). Outpatients who met DSM-IV-TR criteria for a major depressive episode that had lasted ≥ 8 weeks with an inadequate response to prospective antidepressant treatment were randomized to adjunctive aripiprazole or placebo for 6 weeks. Sexual functioning was assessed using the Massachusetts General Hospital Sexual Functioning Inventory (MGH-SFI). To assess whether adjunctive aripiprazole improves sexual functioning directly, rather than as an indirect effect of improvement in depression symptoms, the mean change in MGH-SFI item scores and overall improvement scores was assessed using analysis of covariance, with double-blind baseline and change in MADRS total score as covariates. Correlations between MGH-SFI items and MADRS total score and prolactin levels were also assessed.

Results: The analysis included 1,092 subjects (n = 737 female and n = 355 male). In the total population, adjunctive aripiprazole demonstrated statistically significant greater improvements versus placebo on the MGH-SFI item “interest in sex” (−0.34 vs −0.18, P < .05). In males, no significant treatment differences were observed. In females, improvements in sexual functioning with adjunctive aripiprazole versus placebo were found on the MGH-SFI items “interest in sex” (−0.41 vs −0.21, P < .05) and “sexual satisfaction” (−0.44 vs −0.25, P < .05).

Conclusions: Aripiprazole adjunctive to antidepressant treatment can have some beneficial effects on sexual functioning in patients with major depressive disorder who respond inadequately to standard antidepressant treatment; the benefits in women were specific to sexual interest and satisfaction and were independent of the improvement in depressive symptoms.

Trial Registration: Identifiers: NCT00095823, NCT00095758, and NCT00105196

Prim Care Companion CNS Disord 2011;13(1):e1–e10

Submitted: March 30, 2010; accepted June 8, 2010.

Published online: January 13, 2011 (doi:10.4088/PCC.10m00994gre).

Corresponding author: Maurizio Fava, MD, Department of Psychiatry, Massachusetts General Hospital, 55 Fruit St, Bulfinch 351, Boston, MA 02114 (