A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
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ClinicalTrials.gov Identifier: NCT00644982 |
Recruitment Status
:
Completed
First Posted
: March 27, 2008
Last Update Posted
: April 10, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder, Major | Drug: sertraline Drug: venlafaxine XR | Phase 4 |
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 |

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.
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- 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. ]
- 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. ]
- The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8). [ Time Frame: Week 8 ]
- CGI response rate at endpoint (week 8). [ Time Frame: Week 8 ]
- Change from baseline in the CGI-Severity Scale (CGI-S). [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10. ]
- Change from baseline in the Hamilton Anxiety Scale (HAM-A). [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10. ]
- Change from baseline in the Endicott Work Productivity Scale (EWPS). [ Time Frame: Weeks 1, 8, 9, 10 ]
- Change from baseline in the Visual Analogue Scale (VAS) for Depression. [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 9 and 10. ]
- 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 ]
- Change from baseline in the Clinical Global Impression-Improvement Scale. [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644982
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 Key Record Dates |
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 |