A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644982

Purpose

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

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: sertraline Drug: venlafaxine XR	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	163
Study Start Date:	October 2002
Study Completion Date:	September 2003

Arms	Assigned Interventions
Sertaline group: Experimental	Drug: sertraline Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
Venlafaxine group: Active Comparator	Drug: venlafaxine XR Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644982

Locations

Australia, Queensland
Pfizer Investigational Site
EVERTON PARK, Queensland, Australia, 4053
Pfizer Investigational Site
CAIRNS, Queensland, Australia, 4870
Pfizer Investigational Site
North Cairns, Queensland, Australia, 4870
Australia, Victoria
Pfizer Investigational Site
WEST HEIDELBERG, Victoria, Australia, 3081
Pfizer Investigational Site
Box Hill, Victoria, Australia, 3128
Pfizer Investigational Site
HEIDELBERG, Victoria, Australia, 3084
Pfizer Investigational Site
BOX HILL, Victoria, Australia, 3128
Australia, Western Australia
Pfizer Investigational Site
WEST PERTH, Western Australia, Australia, 6005
Turkey
Pfizer Investigational Site
IZMIR, Turkey
Pfizer Investigational Site
MALATYA, Turkey
Pfizer Investigational Site
ANKARA, Turkey
Pfizer Investigational Site
ISTANBUL, Turkey
Pfizer Investigational Site
DIYARBAKIR, Turkey
Pfizer Investigational Site
IZMIT, Turkey
Pfizer Investigational Site
ADANA, Turkey

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0501066
Study First Received:	March 24, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00644982 History of Changes
Health Authority:	Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Venlafaxine
Mood Disorders
Sertraline
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010