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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90210 United States
Contact
1-800-718-1021
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without
psychotic features.

- Depressive symptoms for at least 30 days before the screening visit.

- Outpatient men and women at least 18 years of age.

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

- Significant risk of suicide based on clinical judgment, including common suicidal
thoughts and suicide having been considered as a possible solution even without
specific plans or intent.

- Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, or any other medical condition that might
confound the study or put the subject at greater risk during study participation.

- Current (within 12 months before baseline) psychoactive substance abuse or dependence
(including alcohol), manic episode, posttraumatic stress disorder,
obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
disorder; b) current (within 12 months before baseline) generalized anxiety disorder,
panic disorder, or social anxiety disorder; c) presence (within 12 months before
baseline) of a clinically important personality disorder as assessed during the
psychiatric assessments.

NCT00384033
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

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Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
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 (DVS SR)
    50 mg tablet, once daily dosing for 8 weeks
  • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    100 mg tablet, once daily dosing for 8 weeks
  • Drug: Placebo
    Matching placebo tablets and capsules, once daily dosing for 8 weeks
  • Drug: Duloxetine 60 mg/day
    60 mg capsule, once daily dosing for 8 weeks
  • Experimental: Desvenlafaxine succinate sustained-release 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Experimental: Desvenlafaxine succinate sustained-release 100 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Duloxetine 60mg
    Active control to assess assay sensitivity
    Intervention: Drug: Duloxetine 60 mg/day


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
638
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
  • Depressive symptoms for at least 30 days before the screening visit.
  • Outpatient men and women at least 18 years of age.

Exclusion Criteria:

  • Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
  • Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
  • Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00384033
3151A1-335
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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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