title: Evaluation of the effect of duloxetine treatment on functioning as measured by the Sheehan disability scale:  pooled analysis of data from six randomized, double-blind, placebo-controlled clinical studies.
abstract: The purpose of this work is to describe the effect of duloxetine on functioning as measured by the Sheehan disability scale (SDS) compared with placebo in patients with major depressive disorder (MDD). Pooled data from six randomized, parallel, double-blind, placebo-controlled duloxetine studies in adult MDD patients were analyzed at the short-term (7-13 weeks) and the long-term (>24 weeks) endpoint. The primary variable was the SDS total score. Secondary variables included functional remission (SDS total ≤ 6) rates, Hamilton rating scale for depression total score, and pain visual analog scale. Analysis of covariance and logistic regression methods were used to assess differences in treatment and identify prognostic baseline factors. In total, 2496 patients (1424 duloxetine; 1072 placebo) were included. The between-treatment difference of -2.52 between duloxetine and placebo in the SDS total score at the short-term endpoint was statistically significant in favor of duloxetine vs. placebo (95% confidence interval: -3.17, -1.87; P < 0.001). The endpoint functional remission rates were 39.5% with duloxetine and 28.7% with placebo. Time since first depression episode, antidepressant pretreatment (yes/no), baseline visual analog scale pain (≤30 / >30 mm), and sex were significant prognostic factors. The effect of duloxetine was maintained at the long-term endpoint. Duloxetine is effective in improving MDD patients' functioning. Further antidepressant studies focusing on functioning would be helpful.
authors.affiliation: Eli Lilly and Company, Sesto Fiorentino, Italy. mancini_michele@lilly.com
authors.forename: Michele
authors.initials: M
authors.lastname: Mancini
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
authors.forename: Koen
authors.initials: K
authors.lastname: Demyttenaere
authors.forename: Mario
authors.initials: M
authors.lastname: Amore
authors.forename: Walter
authors.initials: W
authors.lastname: Deberdt
authors.forename: Deborah
authors.initials: D
authors.lastname: Quail
authors.forename: Doron
authors.initials: D
authors.lastname: Sagman
mesh_terms: D000328:Adult; D000368:Aged; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D004185:Disability Evaluation; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012720:Severity of Illness Index; D013223:Statistics as Topic / Q000592:standards; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013876:Thiophenes; D000068736:Duloxetine Hydrochloride