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

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NCT00644982

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Study Location
Pfizer Investigational Site
Cairns, Queensland, 4870, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)


- Current or past diagnosis of bipolar disorder or any psychotic disorder.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Official Title  ICMJE A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
Brief Summary To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: sertraline
    Flexibly-titrated 50 mg tablets, 50-150 mg/day and venlafaxine placebo orally for 10 weeks.
    Other Name: Zoloft
  • Drug: venlafaxine XR
    Flexibly-titrated 75 mg capsules, 75-225mg/day and sertraline placebo orally for 10 weeks.
Study Arms  ICMJE
  • Experimental: Sertaline group
    Intervention: Drug: sertraline
  • Active Comparator: Venlafaxine group
    Intervention: Drug: venlafaxine XR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)		163
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644982
Other Study ID Numbers  ICMJE A0501066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP