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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644982
First received: March 24, 2008
Last updated: April 7, 2008
Last verified: April 2008
  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:


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
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

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:
No publications provided

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
Sertraline
Venlafaxine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 28, 2014