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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644982
• Other study ID #: A0501066
• Status: Completed
• Phase: Phase 4
• Start date: October 2002
• Est. completion date: September 2003

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Box Hill	Victoria
Australia	Pfizer Investigational Site	Cairns	Queensland
Australia	Pfizer Investigational Site	Everton Park	Queensland
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	North Cairns	Queensland
Australia	Pfizer Investigational Site	WEST Heidelberg	Victoria
Australia	Pfizer Investigational Site	West Perth	Western Australia
Turkey	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

Sponsors (1)

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

Countries where clinical trial is conducted

Australia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	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.		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).		Week 8
Secondary	CGI response rate at endpoint (week 8).		Week 8
Secondary	Change from baseline in the CGI-Severity Scale (CGI-S).		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	Change from baseline in the Hamilton Anxiety Scale (HAM-A).		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	Change from baseline in the Endicott Work Productivity Scale (EWPS).		Weeks 1, 8, 9, 10
Secondary	Change from baseline in the Visual Analogue Scale (VAS) for Depression.		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.		Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
Secondary	Hamilton-Depression Rating Scale remission rates at endpoint (week 8).		Week 8
Secondary	Change from baseline in the Clinical Global Impression-Improvement Scale.		Weeks 1, 2, 3, 4, 6, 8

External Links

•   To obtain contact information for a study center near you, click here.