Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
Lead Sponsor:
Pfizer
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
Eligibility Criteria
Inclusion
- A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
- Depressive symptoms for at least 30 days before the screening visit.
- Outpatient men and women at least 18 years of age.
Exclusion
- 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.
- Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT00384033
Start Date
September 1 2006
End Date
September 1 2007
Last Update
March 15 2012
Active Locations (22)
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1
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
2
Pfizer Investigational Site
Burbank, California, United States, 91506
3
Pfizer Investigational Site
Encino, California, United States, 91316
4
Pfizer Investigational Site
Los Alamitos, California, United States, 90720