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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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, Adana, Turkey

Pfizer Investigational Site, Ankara, Turkey

Pfizer Investigational Site, Diyarbakir, Turkey

Pfizer Investigational Site, Istanbul, Turkey

Pfizer Investigational Site, Izmir, Turkey

Pfizer Investigational Site, Izmit, Turkey

Pfizer Investigational Site, Malatya, Turkey

Pfizer Investigational Site, Cairns, Queensland 4870, Australia

Pfizer Investigational Site, Everton Park, Queensland 4053, Australia

Pfizer Investigational Site, North Cairns, Queensland 4870, 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.

Starting date: October 2002
Last updated: April 7, 2008

Page last updated: August 23, 2015

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