Status:
COMPLETED
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Detailed Description
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subje...
Eligibility Criteria
Inclusion
- Primary
- Outpatient men and women at least 18 years of age.
- Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
- Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
- Primary
Exclusion
- Treatment with DVS SR at any time in the past.
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT00445679
Start Date
July 1 2007
End Date
February 1 2009
Last Update
November 4 2013
Active Locations (43)
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1
Beijing, China, 100083
2
Beijing, China, 100088
3
Guangdong Province, China, 510370
4
Hunan Province, China, 410011