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

Last updated on November 17, 2019

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Study Location
Pfizer Investigational Site
Cairns, Queensland, 4870 Australia
Contact
1-800-718-1021
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.
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- 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.

NCT00644982
Pfizer
Completed
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression

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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
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 SummaryTo assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
Detailed DescriptionNot 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 DateNot 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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