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 - 2011/10/27/entrez PY - 2011/10/27/pubmed PY - 2012/4/7/medline SP - 17 EP - 26 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 27 IS - 1 N2 - 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. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/22027844/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_ L2 - https://doi.org/10.1097/YIC.0b013e32834ce11b DB - PRIME DP - Unbound Medicine ER -