ORIGINAL ARTICLESA randomized, double-blind, and placebo-controlled trial of quetiapine augmentation of fluoxetine in major depressive disorderGarakani, Amira; Martinez, Jose M.a; Marcus, Suea; Weaver, Jamesa; Rickels, Karlb; Fava, Maurizioc; Hirschowitz, JackaAuthor Information aDepartment of Psychiatry, Mount Sinai School of Medicine, New York, New York bDepartment of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania cDepression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA Correspondence to Dr Jack Hirschowitz, MD, Department of Psychiatry, Mount Sinai School of Medicine, 903 Park Avenue, Suite 2A, New York, NY 10075, USA Tel: +1 212 734 0472; fax: +1 212 734 0472; e-mail: [email protected] Received 16 November 2007 Accepted 20 March 2008 International Clinical Psychopharmacology: September 2008 - Volume 23 - Issue 5 - p 269-275 doi: 10.1097/YIC.0b013e328301a74c Buy Metrics Abstract The objective of this study was to investigate whether quetiapine, when compared with placebo, can speed the onset of action and improve the quality of response to fluoxetine treatment in patients suffering from major depressive disorder. A total of 114 patients with major depressive disorder were enrolled in an 8-week treatment study. Patients were initiated on a course of fluoxetine treatment and randomized to quetiapine or placebo. Quetiapine was flexibly dosed starting at 25 mg to a maximum of 100 mg daily. Mixed-effects regression showed that quetiapine plus fluoxetine did not achieve 50% reduction in the Montgomery–Åsberg Depression Rating Scale score or improvement in Hamilton Anxiety Scale, Clinical Global Improvement (CGI)-Severity, and CGI-Improvement scores sooner than the fluoxetine plus placebo group; however both groups improved in all scores over time. Mixed-effects linear regression of insomnia scores showed that the quetiapine plus fluoxetine group improved significantly more rapidly compared with the fluoxetine plus placebo group. The study indicates that quetiapine plus fluoxetine did not achieve a reduction in the Montgomery–Åsberg Depression Rating Scale score or improvement in Hamilton Anxiety Scale or CGI scores from baseline sooner than the fluoxetine plus placebo group. The combination of quetiapine and fluoxetine, however, improved sleep over fluoxetine alone over the first few weeks of treatment. © 2008 Lippincott Williams & Wilkins, Inc.