Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT00863798
Start Date
April 1 2009
End Date
March 1 2010
Last Update
May 6 2011
Active Locations (24)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
2
Pfizer Investigational Site
Encino, California, United States, 91316
3
Pfizer Investigational Site
Newport Beach, California, United States, 92660
4
Pfizer Investigational Site
Redlands, California, United States, 92374