A Phase 3 interventional study of sertraline and venlafaxine XR in Major Depressive Disorder, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Vanderbilt University · Phase 3, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Vanderbilt University