Status:
COMPLETED
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Lead Sponsor:
Pfizer
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
924 Patients enrolled
Trial Details
Trial ID
NCT01432457
Start Date
October 1 2011
End Date
August 1 2012
Last Update
January 20 2014
Active Locations (61)
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1
Dedicated Clinical Research
Phoenix, Arizona, United States, 85020
2
Deidcated Clinical Research
Phoenix, Arizona, United States, 85020
3
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States, 72223
4
Pacific Clinical Research Medical Group
Arcadia, California, United States, 91007