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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: sertraline; Drug: venlafaxine XR	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	163 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	October 2002
Actual Study Completion Date :	September 2003

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Sertaline group	Drug: sertraline; Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.; Other Name: Zoloft
Active Comparator: Venlafaxine group	Drug: venlafaxine XR; Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Australia, Queensland
Pfizer Investigational Site
Cairns, Queensland, Australia, 4870
Pfizer Investigational Site
Everton Park, Queensland, Australia, 4053
Pfizer Investigational Site
North Cairns, Queensland, Australia, 4870
Australia, Victoria
Pfizer Investigational Site
Box Hill, Victoria, Australia, 3128
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Pfizer Investigational Site
West Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Pfizer Investigational Site
West Perth, Western Australia, Australia, 6005
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, Turkey

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00644982 History of Changes
Other Study ID Numbers:	A0501066
First Posted:	March 27, 2008
Last Update Posted:	April 10, 2008
Last Verified:	April 2008

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Sertraline; Venlafaxine Hydrochloride; Antidepressive Agents; Psychotropic Drugs	Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Second-Generation