Back to resultsA Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
sertraline
venlafaxine XR
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sertaline group
Venlafaxine group
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Secondary Outcome Measures
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.
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
CGI response rate at endpoint (week 8).
Change from baseline in the CGI-Severity Scale (CGI-S).
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
Change from baseline in the Clinical Global Impression-Improvement Scale.
Full Information
NCT ID
NCT00644982
First Posted
March 24, 2008
Last Updated
January 25, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00644982
Brief Title
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sertaline group
Arm Type
Experimental
Arm Title
Venlafaxine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
venlafaxine XR
Intervention Description
Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary Outcome Measure Information:
Title
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.
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Title
The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
Time Frame
Week 8
Title
CGI response rate at endpoint (week 8).
Time Frame
Week 8
Title
Change from baseline in the CGI-Severity Scale (CGI-S).
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Title
Change from baseline in the Hamilton Anxiety Scale (HAM-A).
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Title
Change from baseline in the Endicott Work Productivity Scale (EWPS).
Time Frame
Weeks 1, 8, 9, 10
Title
Change from baseline in the Visual Analogue Scale (VAS) for Depression.
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Title
Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Title
Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
Time Frame
Week 8
Title
Change from baseline in the Clinical Global Impression-Improvement Scale.
Time Frame
Weeks 1, 2, 3, 4, 6, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Pfizer Investigational Site
City
Everton Park
State/Province
Queensland
ZIP/Postal Code
4053
Country
Australia
Facility Name
Pfizer Investigational Site
City
North Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Pfizer Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Pfizer Investigational Site
City
WEST Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Pfizer Investigational Site
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adana
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Diyarbakir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmit
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Malatya
Country
Turkey
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0501066&StudyName=A%20comparison%20of%20Sertraline%20versus%20Venlafaxine%20XR%20in%20the%20treatment%20of%20major%20depression.
Description
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Learn more about this trial
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
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