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

Phase 4

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: venlafaxine XR; Drug: sertraline

• Registration Number: NCT00644982
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2003-09
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venlafaxine group	venlafaxine XR	-
Sertaline group	sertraline	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 Hamilton Anxiety Scale (HAM-A).	Weeks 1, 2, 3, 4, 6, 8, 9 and 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 Clinical Global Impression-Improvement Scale.	Weeks 1, 2, 3, 4, 6, 8
Change from baseline in the Endicott Work Productivity Scale (EWPS).	Weeks 1, 8, 9, 10

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Malatya, Turkey