Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder
Lead Sponsor:
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 DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study wi...
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 judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
709 Patients enrolled
Trial Details
Trial ID
NCT00798707
Start Date
December 1 2008
End Date
April 1 2010
Last Update
June 10 2011
Active Locations (78)
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1
Pfizer Investigational Site
Arcadia, California, United States, 91007
2
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
3
Pfizer Investigational Site
Cerritos, California, United States, 90703
4
Pfizer Investigational Site
Garden Grove, California, United States, 92845