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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00644982 |
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Condition | Intervention | Phase |
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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 |
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.
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Venlafaxine group: Active Comparator |
Drug: venlafaxine XR
Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
Neurotransmitter Agents Depression Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Serotonin |
Behavioral Symptoms Mental Disorders Venlafaxine Mood Disorders Sertraline Antidepressive Agents, Second-Generation Antidepressive Agents |
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 |