Status:
COMPLETED
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and t...
Eligibility Criteria
Inclusion
- Inclusion criteria in the open-label phase:
- Outpatients
- Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception)
- Subjects must 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 (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.)
- Exclusion Criteria:
- Treatment with DVS-233 SR at any time in the past
- Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
- Known hypersensitivity to venlafaxine (IR or ER)
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT00075257
End Date
August 1 2005
Last Update
August 19 2009
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