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Completed

NCT Number: NCT00644982

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

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

Completed

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Cairns, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.

Other names: Zoloft

venlafaxine XR

Drug

Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).

    Time frame: Week 8

  3. CGI response rate at endpoint (week 8).

    Time frame: Week 8

  4. Change from baseline in the CGI-Severity Scale (CGI-S).

    Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.

  5. Change from baseline in the Hamilton Anxiety Scale (HAM-A).

    Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.

  6. Change from baseline in the Endicott Work Productivity Scale (EWPS).

    Time frame: Weeks 1, 8, 9, 10

  7. Change from baseline in the Visual Analogue Scale (VAS) for Depression.

    Time frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.

  8. 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.

  9. Hamilton-Depression Rating Scale remission rates at endpoint (week 8).

    Time frame: Week 8

  10. Change from baseline in the Clinical Global Impression-Improvement Scale.

    Time frame: Weeks 1, 2, 3, 4, 6, 8

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Mar 27, 2008
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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