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.

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.

• Authors: 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
• Journal: International clinical psychopharmacology (Int Clin Psychopharmacol) Vol. 27 Issue 1 Pg. 17-26 (Jan 2012) ISSN: 1473-5857 [Electronic] England
• PMID: 22027844 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic Uptake Inhibitors
• Antidepressive Agents
• Drugs, Generic
• Serotonin Uptake Inhibitors
• Thiophenes
• Duloxetine Hydrochloride

Topics

• Adrenergic Uptake Inhibitors (adverse effects, therapeutic use)
• Adult
• Antidepressive Agents (adverse effects, therapeutic use)
• Depressive Disorder, Major (diagnosis, drug therapy, psychology)
• Disability Evaluation
• Drugs, Generic (adverse effects, therapeutic use)
• Duloxetine Hydrochloride
• Female
• Humans
• Male
• Middle Aged
• Outpatients
• Prospective Studies
• Psychiatric Status Rating Scales
• Remission Induction
• Selective Serotonin Reuptake Inhibitors (adverse effects, therapeutic use)
• Severity of Illness Index
• Thiophenes (adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome
• United States