Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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NCT00824291

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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
19-74 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.

- Employed for 20 hours or more for a minimum of 1 month prior to baseline.

- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

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


- Treatment with desvenlafaxine succinate sustained release at any time in the past
and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.


- Treatment-resistant defined as any of the following failed treatments in the past 3
years: 3 or more previous adequate trials of >=2 classes of antidepressant medication,
electroconvulsive therapy, or psychotherapy (2 adequate trials).


- Current (within 12 months prior to the screening visit) psychoactive substance abuse
or dependence (including alcohol), manic episode, posttraumatic stress disorder,
obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
disorder.


- Clinically important abnormalities on physical examination, electrocardiogram (ECG),
or laboratory evaluations.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Official Title  ICMJE A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
Brief Summary This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    50 mg/day oral tablet for 12 weeks
    Other Name: Pristiq
  • Genetic: Genotyping
    CYP2D6 genotyping at randomization
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Experimental: 2
    Intervention: Genetic: Genotyping
Publications *

*   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: November 30, 2010)		437
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2009)		400
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
  • Employed for 20 hours or more for a minimum of 1 month prior to baseline.
  • Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.

Exclusion Criteria:

  • Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
  • Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of >=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
  • Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
  • Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years to 74 Years   (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 Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00824291
Other Study ID Numbers  ICMJE 3151A1-4415
B2061006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2011

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