Analysis of depressive symptoms in patients with major depressive disorder treated with desvenlafaxine or placebo.
BACKGROUND
The aim of this study was to evaluate the impact of desvenlafaxine on a broad range of major depressive disorder (MDD) symptoms.


METHODS
Data were pooled from 9 double-blind, randomized, placebo-controlled, 8-week studies of desvenlafaxine in adult outpatients with MDD. Intent-to-treat participants received fixed- (50, 100, 200, or 400 mg/d; n = 1342) or flexible-dose (100 to 400 mg/d, n = 463) desvenlafaxine or placebo (n = 1108). Final on-therapy scores for individual items of the 17-item Hamilton Rating Scale for Depression (HAMD17) and the Montgomery Asberg Depression Rating Scale (MADRS) were compared between groups using analysis of covariance. Efficacy at different doses was examined using the subset of fixed-dose studies.


RESULTS
Based on differences in adjusted mean changes from baseline (desvenlafaxine vs placebo), statistically significant advantages with desvenlafaxine (50 to 400 mg/d, all doses pooled) vs placebo were seen for 10 of the 17 HAM-D17 items: depressed mood (-0.4; P < 0.001), feelings of guilt (-0.2; P < 0.001), suicide (-0.1; P < 0.001), late insomnia (-0.1; P = 0.001), work and activities (-0.2; P < 0.001), psychomotor retardation (-0.1; P < 0.001), agitation (-0.1; P < 0.001), psychic anxiety (-0.3; P < 0.001), general somatic symptoms (-0.2; P < 0.001), and genital symptoms (-0.1; P = 0.003). Desvenlafaxine (50 to 400 mg/d, pooled) was significantly better than placebo on all MADRS items (range: -0.1 to -0.5; all P </= 0.019), except "reduced appetite" (-0.01, P > 0.05). Symptom relief was similar with all desvenlafaxine doses examined, including 50 mg/d.


CONCLUSIONS
Shortterm desvenlafaxine therapy (50 to 400 mg/d) improved a broad range of emotional and physical symptoms in outpatients with MDD.
Kornstein
Susan G
SG
Institute for Women's Health, Virginia Commonwealth University, Richmond, VA, USA. skornste@vcu.edu
Fava
Maurizio
M
Jiang
Qin
Q
Tourian
Karen A
KA
D000328:Adult; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000008:administration & dosage / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000503:physiopathology; D000069468:Desvenlafaxine Succinate; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000928:Antidepressive Agents; D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate