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.
- major depressive disorder
- selective serotonin-reuptake inhibitors
- serotonin and norepinephrine-reuptake inhibitor
ASJC Scopus subject areas
- Psychiatry and Mental health
- Pharmacology (medical)
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 journal › Article
TY - JOUR
T1 - 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
AU - Martinez, James Michael
AU - Katon, Wayne
AU - Greist, John H.
AU - Kroenke, Kurt
AU - Thase, Michael E.
AU - Meyers, Adam L.
AU - Edwards, Sara Elizabeth
AU - Marangell, Lauren B.
AU - Shoemaker, Scarlett
AU - Swindle, Ralph
PY - 2012/1
Y1 - 2012/1
N2 - Lippincott Williams & Wilkins.
AB - Lippincott Williams & Wilkins.
KW - duloxetine
KW - efficacy
KW - major depressive disorder
KW - selective serotonin-reuptake inhibitors
KW - serotonin and norepinephrine-reuptake inhibitor
UR - http://www.scopus.com/inward/record.url?scp=83055180710&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=83055180710&partnerID=8YFLogxK
U2 - 10.1097/YIC.0b013e32834ce11b
DO - 10.1097/YIC.0b013e32834ce11b
M3 - Article
C2 - 22027844
AN - SCOPUS:83055180710
VL - 27
SP - 17
EP - 26
JO - International Clinical Psychopharmacology
JF - International Clinical Psychopharmacology
SN - 0268-1315
IS - 1