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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.
Int Clin Psychopharmacol. 2012 Jan; 27(1):17-26.IC

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+Show Affiliations

Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN 46285, USA. martinezjames@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22027844

Citation

Martinez, James Michael, et al. "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." International Clinical Psychopharmacology, vol. 27, no. 1, 2012, pp. 17-26.
Martinez JM, Katon W, Greist JH, et al. 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. Int Clin Psychopharmacol. 2012;27(1):17-26.
Martinez, J. M., Katon, W., Greist, J. H., Kroenke, K., Thase, M. E., Meyers, A. L., Edwards, S. E., Marangell, L. B., Shoemaker, S., & Swindle, R. (2012). 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. International Clinical Psychopharmacology, 27(1), 17-26. https://doi.org/10.1097/YIC.0b013e32834ce11b
Martinez JM, et al. 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. Int Clin Psychopharmacol. 2012;27(1):17-26. PubMed PMID: 22027844.
* Article titles in AMA citation format should be in sentence-case
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 -