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

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NCT00863798

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35216 United States
See other locations
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
symptoms for at least 30 days prior to screening).

- Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.

- Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

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

- Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from
screening to baseline).

- Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia
Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

NCT00863798
Pfizer
Completed
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

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Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Desvenlafaxine Succinate Sustained-Release 10mg
    10 mg tablet, once daily dosing for 8 weeks
  • Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
    50 mg tablet, once daily dosing for 8 weeks
  • Drug: placebo
    Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.
  • Experimental: Desvenlafaxine succinate sustained release 10 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release 10mg
  • Experimental: Desvenlafaxine succinate sustained release 50 mg
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release 50 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
682
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.
  • Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.

Exclusion Criteria:

  • Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).
  • Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00863798
3151A1-3362
B2061005
3151A1-3362-US
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 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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