A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644982
First received: March 24, 2008
Last updated: April 7, 2008
Last verified: April 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
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 |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644982
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644982
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
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00644982 History of Changes |
| Other Study ID Numbers: | A0501066 |
| Study First Received: | March 24, 2008 |
| Last Updated: | April 7, 2008 |
| Health Authority: | Australia: Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Venlafaxine Hydrochloride Sertraline Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on September 30, 2016