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

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

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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: sertraline; Drug: venlafaxine XR

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Pfizer Investigational Site
    • Everton Park, Queensland, Australia, 4053
      • Pfizer Investigational Site
    • North Cairns, Queensland, Australia, 4870
      • Pfizer Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Pfizer Investigational Site
    • Heidelberg, Victoria, Australia, 3084
      • Pfizer Investigational Site
    • WEST Heidelberg, Victoria, Australia, 3081
      • Pfizer Investigational Site
  • Western Australia
    • West Perth, Western Australia, Australia, 6005
      • Pfizer Investigational Site
• Turkey
  • Adana, Turkey
    • Pfizer Investigational Site
  • Ankara, Turkey
    • Pfizer Investigational Site
  • Diyarbakir, Turkey
    • Pfizer Investigational Site
  • Istanbul, Turkey
    • Pfizer Investigational Site
  • Izmir, Turkey
    • Pfizer Investigational Site
  • Izmit, Turkey
    • Pfizer Investigational Site
  • Malatya, Turkey
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Study Completion (Actual): September 1, 2003

Study Registration Dates

• First Submitted: March 24, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Sertraline; Venlafaxine Hydrochloride
• Other Study ID Numbers: A0501066