Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
19-74 years
Phase:
PHASE3
Brief Summary
This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo ...
Eligibility Criteria
Inclusion
- Outpatient men and women, between the ages of 18 to 75 years, fluent in both written and spoken English.
- Employed for 20 hours or more for a minimum of 1 month prior to baseline.
- Primary diagnosis of Major Depressive Disorder with symptoms for at least 30 days prior to baseline.
Exclusion
- Treatment with desvenlafaxine succinate sustained release at any time in the past and/or venlafaxine (Effexor or Effexor XR) 1 year prior to baseline.
- Treatment-resistant defined as any of the following failed treatments in the past 3 years: 3 or more previous adequate trials of \>=2 classes of antidepressant medication, electroconvulsive therapy, or psychotherapy (2 adequate trials).
- Current (within 12 months prior to the screening visit) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
- Clinically important abnormalities on physical examination, electrocardiogram (ECG), or laboratory evaluations.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00824291
Start Date
February 1 2009
End Date
November 1 2009
Last Update
March 10 2011
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