Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Status: | |
---|---|
Conditions: | Depression, Major Depression Disorder (MDD) |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | October 2011 |
End Date: | September 2012 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase IV, Multicenter, Randomized, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of 2 Fixed Doses (50 and 100 mg/Day) of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of
desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with
major depressive disorder.
Inclusion Criteria:
- Male or female outpatients aged 18 years or older who are fluent in written and
spoken English.
- A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical
Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode,
without psychotic features.
- A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no
more than a 4-point improvement from screening to baseline.
Exclusion Criteria:
- Significant risk of suicide based on clinical judgment.
- 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.
- Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
- History or current evidence of gastrointestinal disease known to interfere with the
absorption or excretion of drugs or a history of surgery known to interfere with the
absorption or excretion of drugs.
- Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic,
or other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results.
We found this trial at
58
sites
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5601 Corporate Way
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
561-238-3036
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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