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Original Articles

Adjunctive Aripiprazole in Major Depressive Disorder: Analysis of Efficacy and Safety in Patients With Anxious and Atypical Features

Madhukar H. Trivedi, MD; Michael E. Thase, MD; Maurizio Fava, MD; J. Craig Nelson, MD; Huyuan Yang, PhD; Ying Qi, PhD; Quynh-Van Tran, PharmD; Andrei Pikalov, MD, PhD; Berit X. Carlson, PhD; Ronald N. Marcus, MD; and Robert M. Berman, MD

Published: December 31, 2008

Article Abstract

Objective: To evaluate the efficacy of adjunctive aripiprazole to standard antidepressant therapy (ADT) for patients with DSM-IV major depressive disorder with anxious/atypical features at baseline.

Method: Data from 2 identical 14-week studies (an 8-week prospective ADT treatment phase and a 6-week randomized, double-blind phase) of aripiprazole augmentation were pooled to evaluate efficacy and safety in the 2 subgroups. The primary efficacy endpoint was mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from end of ADT treatment to end of randomized treatment (last observation carried forward). Anxious depression was defined by a Hamilton Rating Scale for Depression anxiety/somatization factor score >= 7, and atypical depression was defined by previously described criteria on the Inventory of Depressive Symptomatology-Self-Report. Both anxious and atypical subtypes were defined based on symptoms at entry into prospective ADT (week 0). Patients were enrolled between June 2004 and April 2006 in one study and from September 2004 to December 2006 in the other (total randomized population, N = 742; anxious/nonanxious population, N = 740; atypical/nonatypical population, N = 737).

Results: Completion rates were between 84% and 90% and comparable across all subgroups, with low discontinuations due to adverse events. Patients receiving adjunctive aripiprazole demonstrated significantly greater improvement in MADRS total score versus patients receiving adjunctive placebo, starting at week 1 or week 2 and continuing through to endpoint (anxious: -8.72 vs. -6.17, p <= .001; nonanxious: -8.61 vs. -4.97, p <= .001; atypical: -9.31 vs. -5.15, p <= .001; nonatypical: -8.08 vs.
-6.22, p < .05). At endpoint, remission rates were also significantly higher with adjunctive aripiprazole versus adjunctive placebo (p < .05) in all subgroups. Treatment emergent adverse event profile was similar in all subgroups and comparable to the total population. Reporting of akathisia and weight gain on aripiprazole treatment did not differ between subgroups.

Conclusion: Adjunctive aripiprazole is an effective treatment for patients with major depression presenting with either anxious or atypical features.

Trial Registration: Identifiers: NCT00095823 and NCT00095758

Volume: 69

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