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

NCT00092911

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Depressive Disorder, 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

- Outpatients

- Men and women age 18 years of age and older

- Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

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 extended release [ER]) within 90
days of study day 1


- Known hypersensitivity to venlafaxine (IR or ER)


- Significant risk of suicide based on clinical judgment, including common

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder
Brief Summary The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Disorder
  • Major Depressive Disorder
Intervention  ICMJE Drug: DVS-233 SR
Study Arms  ICMJE Not Provided
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: August 18, 2009)
244
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatients
  • Men and women age 18 years of age and older
  • Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

Exclusion Criteria:

  • Treatment with DVS-233 SR at any time in the past
  • Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER)
  • Significant risk of suicide based on clinical judgment, including common
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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00092911
Other Study ID Numbers  ICMJE 3151A1-320
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

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