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

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NCT00824291

Last updated on May 10, 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
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.

NCT00824291
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate Functional Outcome In Outpatients With Major Depressive Disorder Treated With Desvenlafaxine Succinare Sustained Release
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: desvenlafaxine succinate sustained release
    50 mg/day oral tablet for 12 weeks
    Other Name: Pristiq
  • Genetic: Genotyping
    CYP2D6 genotyping at randomization
  • Placebo Comparator: 1
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Experimental: 2
    Intervention: Genetic: Genotyping


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
437
November 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT00824291
3151A1-4415
B2061006
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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