title: Efficacy of desvenlafaxine 50 mg compared with placebo in patients with moderate or severe major depressive disorder: a pooled analysis of six randomized, double-blind, placebo-controlled studies.
abstract: This study assessed the efficacy of desvenlafaxine 50 mg/day compared with placebo for treating moderate or severe major depressive disorder (MDD). Data were pooled from six double-blind, placebo-controlled, desvenlafaxine 50 mg/day fixed-dose studies in adults with MDD. The primary endpoint was improvement in 17-item Hamilton Rating Scale for Depression (HAM-D17) scores from baseline at week 8. HAM-D17 changes were evaluated in patients with moderate (18<HAM-D17<25) or severe (HAM-D17≥25) MDD at baseline using analysis of covariance with treatment, study, and baseline in the model. The pooled analysis included 2189 patients (desvenlafaxine 50 mg, n=1150; placebo, n=1039). Of those, 694 (32%) patients had severe depression at baseline. Desvenlafaxine improved HAM-D17 scores versus placebo in patients with either moderate [desvenlafaxine, adjusted mean (±SE), -10.26±0.24; placebo, -8.87±0.26; P<0.001] or severe MDD (desvenlafaxine, -11.91±0.40; placebo, -9.85±0.42; P<0.001). Both moderately and severely depressed patients had significantly higher rates of response and remission with desvenlafaxine treatment compared with placebo (all P's≤0.029). Results were similar when baseline severity was defined by Montgomery-Åsberg Depression Rating Scale or Sheehan Disability Scale scores. Desvenlafaxine 50 mg/day significantly improved depressive symptoms regardless of severity at baseline and was effective in treating both moderate and severe MDD.
authors.affiliation: aMassachusetts General Hospital, Harvard Medical School bDepartment of Family Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts cPfizer Inc., Collegeville, Pennsylvania, USA.
authors.forename: George I
authors.initials: GI
authors.lastname: Papakostas
authors.forename: Larry
authors.initials: L
authors.lastname: Culpepper
authors.forename: Rana S
authors.initials: RS
authors.lastname: Fayyad
authors.forename: Jeff
authors.initials: J
authors.lastname: Musgnung
authors.forename: Christine J
authors.initials: CJ
authors.lastname: Guico-Pabia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D000069468:Desvenlafaxine Succinate; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate