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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ham-D (Hamilton Depression Rating Scale for Depression) 17-item
Clinical Global Impression - Severity Scale
Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Treatment Emergent Symptom Scale-Revised (TESS-R)
Brief Symptom Inventory (BSI)
NEO-5 factor Inventory (NEO-FFI)
Anxiety Sensitivity Inventory (ASI)
Mood Disorder Questionnaire (MDQ)
Ham-A (Hamilton Rating Scale for Anxiety)
Arizona Sexual Functioning Inventory (A-SEX)
Atypical Features Inventory
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