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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: sertraline
  • Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
• Drug: venlafaxine XR
  • Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Sertaline group
• Active Comparator: Venlafaxine group

Primary Measures

• 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.
    Safety Issue?: No

Secondary 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.
  • Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
    Safety Issue?: No
• The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).
  • Time Frame: Week 8
    Safety Issue?: No
• CGI response rate at endpoint (week 8).
  • Time Frame: Week 8
    Safety Issue?: No
• Change from baseline in the CGI-Severity Scale (CGI-S).
  • Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
    Safety Issue?: No
• Change from baseline in the Hamilton Anxiety Scale (HAM-A).
  • Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
    Safety Issue?: No
• Change from baseline in the Endicott Work Productivity Scale (EWPS).
  • Time Frame: Weeks 1, 8, 9, 10
    Safety Issue?: No
• Change from baseline in the Visual Analogue Scale (VAS) for Depression.
  • Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
    Safety Issue?: No
• 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.
    
• Hamilton-Depression Rating Scale remission rates at endpoint (week 8).
  • Time Frame: Week 8
    Safety Issue?: No
• Change from baseline in the Clinical Global Impression-Improvement Scale.
  • Time Frame: Weeks 1, 2, 3, 4, 6, 8
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644982

Study ID Number: A0501066

ClinicalTrials.gov Identifier: NCT00644982

Health Authority: Australia: Therapeutic Goods Administration

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