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A pragmatic 12-week, randomized trial of duloxetine versus generic selective serotonin-reuptake inhibitors in the treatment of adult outpatients in a moderate-to-severe depressive episode

Martinez, James Michaela; Katon, Wayned; Greist, John H.e; Kroenke, Kurtb,c; Thase, Michael E.f,g; Meyers, Adam L.a; Edwards, Sara Elizabetha; Marangell, Lauren B.a; Shoemaker, Scarletta; Swindle, Ralpha

International Clinical Psychopharmacology: January 2012 - Volume 27 - Issue 1 - p 17–26
doi: 10.1097/YIC.0b013e32834ce11b
Original Articles

Some evidence suggests that medications that modulate both serotonin and norepinephrine may be more effective than selective serotonin-reuptake inhibitors (SSRIs) in severe major depressive disorder (MDD). This prospective pragmatic trial tests this hypothesis. Patients with severe MDD were randomly assigned to either duloxetine (a serotonin and norepinephrine-reuptake inhibitor) or physicians’ choice of four generic SSRIs. Nonblinded, flexibly dosed treatment was used to mimic clinical practice. To address potential investigator bias, the patient-reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) was used as the primary efficacy outcome measure. A total of 750 outpatients (19.2%, African descent; 14.8%, Hispanic) were randomized. The primary outcome, remission at week 12 by QIDS-SR, was numerically greater for duloxetine compared with SSRIs (36 vs. 32%), but this difference was not statistically significant. Mean changes in secondary outcomes were significantly superior in favor of duloxetine for the Hamilton Depression Scale-17 item, the Brief Pain Inventory, and the Sheehan Disability Scale. Remission superiority on the QIDS-SR was not achieved. Significantly greater benefit for duloxetine compared with SSRIs was demonstrated on measures of pain and functioning. Study demographics suggest a more generalizable racial and ethnic population than is typical in randomized clinical trials.

aLilly USA, LLC

bSchool of Medicine, Indiana University; VA HSR&D Center for Implementing Evidence-Based Practice, Roudebush VMAC

cRegenstrief Institute, Indianapolis, Indiana

dDepartment of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington

eHealthcare Technology System, Madison, Wisconsin

fDepartments of Psychiatry, University of Pennsylvania School of Medicine, and Philadelphia Veterans Affairs Medical Center

gUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

Correspondence to James Michael Martinez, MD, Lilly Corporate Center, Drop Code 1544, Indianapolis, IN 46285, USA Tel: +1 317 433 2907; fax: +1 317 276 6026; e-mail: martinezjames@lilly.com

Received March 14, 2011

Accepted September 7, 2011

© 2012 Lippincott Williams & Wilkins, Inc.