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

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NCT00075257

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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)

NCT00075257
Pfizer
Completed
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

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

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Major Depressive Disorder
Drug: DVS-233 SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
August 2005
August 2005   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00075257
3151A1-302
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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