To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
396
daily administration during the 10-week treatment phase
daily administration during the 10-week treatment phase
daily administration during the 10-week treatment phase
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Time frame: Randomisation (week 0) And end of the treatment
Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Time frame: Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)
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GSK Investigational Site
Auchenflower, Queensland, Australia
GSK Investigational Site
Kippa-Ring, Queensland, Australia
GSK Investigational Site
Epping, Victoria, Australia
GSK Investigational Site
Heidelberg West, Victoria, Australia
GSK Investigational Site
Liège, Belgium
GSK Investigational Site
Mont-Godinne, Belgium
GSK Investigational Site
Burgas, Bulgaria
GSK Investigational Site
Varna, Bulgaria
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Kelowna, British Columbia, Canada
...and 32 more locations