Major Depressive Disorder Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Parallel-group Study of Sertraline vs. Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
This is a randomized, double-blind, active control, 8-week, flexible dose study of sertraline vs. venlafaxine Extended Release in the acute treatment of Major Depression in male and female outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1 ratio to receive either sertraline or venlafaxine XR based on a computer-generated randomized list.
This is a randomized, double-blind, active control, 8-week, flexible dose study of
sertraline vs. venlafaxine XR in the acute treatment of Major Depression in male and female
outpatient sites that will recruit 15-20 patients each. Subjects will be randomized in a 1:1
ratio to receive either sertraline or venlafaxine XR based on a computer-generated
randomized list.
The primary objectives of the study are: to assess the comparative safety and tolerability
of sertraline and venlafaxine XR and to assess number and severity of discontinuation
symptoms and time to termination of taper at the end of acute treatment with sertraline vs.
venlafaxine XR.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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