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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644982
First received: March 24, 2008
Last updated: April 7, 2008
Last verified: April 2008

March 24, 2008
April 7, 2008
October 2002
Not Provided
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00644982 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8). [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • CGI response rate at endpoint (week 8). [ Time Frame: Week 8 ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • Change from baseline in the Endicott Work Productivity Scale (EWPS). [ Time Frame: Weeks 1, 8, 9, 10 ] [ Designated as 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. ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinical Global Impression-Improvement Scale. [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: sertraline
    Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
    Other Name: Zoloft
  • Drug: venlafaxine XR
    Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
  • Experimental: Sertaline group
    Intervention: Drug: sertraline
  • Active Comparator: Venlafaxine group
    Intervention: Drug: venlafaxine XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
September 2003
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Turkey
 
NCT00644982
A0501066
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP