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Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DVS-233 SR
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria in the open-label phase: Outpatients Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception) Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or ER) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2004
    Last Updated
    August 18, 2009
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00075257
    Brief Title
    Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis. Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    603 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    DVS-233 SR

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria in the open-label phase: Outpatients Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception) Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.) Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or ER) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26137355
    Citation
    McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1):10.4088/PCC.14m01681. doi: 10.4088/PCC.14m01681. eCollection 2015.
    Results Reference
    derived
    PubMed Identifier
    25758058
    Citation
    Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
    Results Reference
    derived

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    Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

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