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

James Michael Martinez, Wayne Katon, John H. Greist, Kurt Kroenke, Michael E. Thase, Adam L. Meyers, Sara Elizabeth Edwards, Lauren B. Marangell, Scarlett Shoemaker, Ralph Swindle

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)17-26
Number of pages10
JournalInternational Clinical Psychopharmacology
Volume27
Issue number1
DOIs
StatePublished - Jan 2012

Fingerprint

Serotonin Uptake Inhibitors
Outpatients
Self Report
Equipment and Supplies
Major Depressive Disorder
Pragmatic Clinical Trials
Pain
Therapeutics
Hispanic Americans
Serotonin
Norepinephrine
Randomized Controlled Trials
Research Personnel
Demography
Outcome Assessment (Health Care)
Depression
Physicians
Duloxetine Hydrochloride
Population

Keywords

  • duloxetine
  • efficacy
  • major depressive disorder
  • selective serotonin-reuptake inhibitors
  • serotonin and norepinephrine-reuptake inhibitor

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

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 Michael; Katon, Wayne; Greist, John H.; Kroenke, Kurt; Thase, Michael E.; Meyers, Adam L.; Edwards, Sara Elizabeth; Marangell, Lauren B.; Shoemaker, Scarlett; Swindle, Ralph.

In: International Clinical Psychopharmacology, Vol. 27, No. 1, 01.2012, p. 17-26.

Research output: Contribution to journalArticle

Martinez, James Michael ; Katon, Wayne ; Greist, John H. ; Kroenke, Kurt ; Thase, Michael E. ; Meyers, Adam L. ; Edwards, Sara Elizabeth ; Marangell, Lauren B. ; Shoemaker, Scarlett ; Swindle, Ralph. / 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. In: International Clinical Psychopharmacology. 2012 ; Vol. 27, No. 1. pp. 17-26.
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