You could be reading the full-text of this article now if you...

If you have access to this article through your institution,
you can view this article in

Efficacy of adjunctive aripiprazole in patients with major depressive disorder who showed minimal response to initial antidepressant therapy

Nelson, James Craiga; Thase, Michael E.b; Bellocchio, Elizabeth E.c; Rollin, Linda M.d; Eudicone, James M.c; McQuade, Robert D.e; Marcus, Ronald N.d; Berman, Robert M.d; Baker, Ross A.e

International Clinical Psychopharmacology:
doi: 10.1097/YIC.0b013e3283502791
Original Articles
Abstract

To evaluate the efficacy of adjunctive aripiprazole in patients with minimal response to prior antidepressant therapy (ADT). Pooled data from three randomized, double-blind, placebo-controlled studies assessing the efficacy of adjunctive aripiprazole to ADT in patients with major depressive disorder who had a minimal response [<25% reduction on the Montgomery–Åsberg Depression Rating Scale (MADRS)] to an 8-week prospective ADT. During the 6-week, double-blind adjunctive phase, response was defined as at least 50% reduction in the MADRS score and remission as at least 50% reduction in MADRS score and a MADRS score ≤10. Rates were examined using analysis of covariance and Cochran–Mantel–Haenszel tests. Kaplan–Meier curves were used to calculate time to response and remission. Of 1038 patients, 72% (n=746) exhibited a minimal response to ADT (ADT minimal responder). Time to response and remission were significantly shorter for ADT minimal responders receiving aripiprazole+ADT versus adjunctive placebo+ADT. ADT minimal responders on aripiprazole+ADT showed significantly greater improvements in MADRS score at endpoint compared with minimal responders on placebo+ADT (−10.3 vs. −6.5, P<0.0001). In addition, ADT minimal responders exhibited significantly higher response rates with aripiprazole+ADT than placebo+ADT (36 vs. 19%, respectively, P<0.0001) and higher remission rates (24 vs. 12%, respectively, P<0.0001). The numbers needed to treat with aripiprazole+ADT were six for response and eight for remission. Aripiprazole augmentation had a rapid and clinically meaningful effect in ADT minimal responders.

Author Information

aUniversity of California, San Francisco, California

bUniversity of Pennsylvania School of Medicine, Philadelphia, Pennsylvania

cBristol-Myers Squibb, Plainsboro, New Jersey

dBristol-Myers Squibb, Wallingford, Connecticut

eOtsuka Pharmaceutical Development and Commercialization Inc., Princeton, New Jersey, USA

Previous presentations: ACNP 2009 Annual meeting, 6–9 December, Hollywood, Florida, USA. Poster 77; APA 2010 Annual meeting, 22–26 May, San Diego, California, USA; NCDEU 2010 Annual meeting, 14–17 June, Boca Raton, Florida, USA; ECNP 2010 Annual meeting, 30 August–1 September, Amsterdam, The Netherlands.

Clinical trial registration: a study of adjunctive aripiprazole in patients with major depressive disorder. ID numbers: NCT00095823, NCT00095758 and NCT00105196. Registry: www.clinicaltrials.gov

Correspondence to James Craig Nelson, MD, Department of Psychiatry, University of California San Francisco, 401 Parnassus Ave, San Francisco, CA 94143, USA Tel: +1 415 476 7405; fax: +1 415 476 7320; e-mail: CraigN@lppi.ucsf.edu

Received October 18, 2011

Accepted December 7, 2011

© 2012 Lippincott Williams & Wilkins, Inc.