A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression

Study Overview
=================
Brief Summary
-----------------
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.

Official Title
-----------------
A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: sertraline
* Drug: venlafaxine XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses. Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2. Exclusion Criteria: Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine) Current or past diagnosis of bipolar disorder or any psychotic disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sertaline group<br> | Drug: sertraline<br>* Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.<br>* Other names: Zoloft;|
| Active Comparator: Venlafaxine group<br> | Drug: venlafaxine XR<br>* Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates. |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 
| The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8). |  | Week 8 | 
| CGI response rate at endpoint (week 8). |  | Week 8 | 
| Change from baseline in the CGI-Severity Scale (CGI-S). |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 
| Change from baseline in the Hamilton Anxiety Scale (HAM-A). |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 
| Change from baseline in the Endicott Work Productivity Scale (EWPS). |  | Weeks 1, 8, 9, 10 | 
| Change from baseline in the Visual Analogue Scale (VAS) for Depression. |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 
| Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain. |  | Weeks 1, 2, 3, 4, 6, 8, 9 and 10. | 
| Hamilton-Depression Rating Scale remission rates at endpoint (week 8). |  | Week 8 | 
| Change from baseline in the Clinical Global Impression-Improvement Scale. |  | Weeks 1, 2, 3, 4, 6, 8 |