A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: sertraline (Drug); venlafaxine XR (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality
of life.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, IZMIR, Turkey
Pfizer Investigational Site, MALATYA, Turkey
Pfizer Investigational Site, ANKARA, Turkey
Pfizer Investigational Site, ADANA, Turkey
Pfizer Investigational Site, DIYARBAKIR, Turkey
Pfizer Investigational Site, IZMIT, Turkey
Pfizer Investigational Site, ISTANBUL, Turkey
Pfizer Investigational Site, EVERTON PARK, Queensland 4053, Australia
Pfizer Investigational Site, CAIRNS, Queensland 4870, Australia
Pfizer Investigational Site, North Cairns, Queensland 4870, Australia
Pfizer Investigational Site, BOX HILL, Victoria 3128, Australia
Pfizer Investigational Site, Box Hill, Victoria 3128, Australia
Pfizer Investigational Site, HEIDELBERG, Victoria 3084, Australia
Pfizer Investigational Site, WEST HEIDELBERG, Victoria 3081, Australia
Pfizer Investigational Site, WEST PERTH, Western Australia 6005, Australia
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: October 2002
Ending date: September 2003
Last updated: April 7, 2008
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