Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Desvenlafaxine Succinate Sustained-Release 10mg (Drug); Desvenlafaxine Succinate Sustained-Release 50 mg (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The primary purpose of this study is to compare the antidepressant efficacy and safety of
two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with
Major Depressive Disorder. The study will also assess changes in sexual function and
general and functional quality of life outcomes.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
Secondary outcome: Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET) Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET) Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET) Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET) Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET) Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET) Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive
symptoms for at least 30 days prior to screening).
- Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20.
- Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.
Exclusion Criteria:
- Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from
screening to baseline).
- Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia
Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
Locations and Contacts
Pfizer Investigational Site, Birmingham, Alabama 35216, United States
Pfizer Investigational Site, Encino, California 91316, United States
Pfizer Investigational Site, Newport Beach, California 92660, United States
Pfizer Investigational Site, Redlands, California 92374, United States
Pfizer Investigational Site, Upland, California 91786, United States
Pfizer Investigational Site, Aurora, Colorado 80045, United States
Pfizer Investigational Site, Denver, Colorado 80204, United States
Pfizer Investigational Site, Cromwell, Connecticut 06416, United States
Pfizer Investigational Site, Maitland, Florida 32751, United States
Pfizer Investigational Site, North Miami, Florida 33161, United States
Pfizer Investigational Site, South Miami, Florida 33143, United States
Pfizer Investigational Site, Indianapolis, Indiana 46260, United States
Pfizer Investigational Site, St. Louis, Missouri 63139, United States
Pfizer Investigational Site, New York, New York 10128, United States
Pfizer Investigational Site, Staten Island, New York 10312, United States
Pfizer Investigational Site, Toledo, Ohio 43623, United States
Pfizer Investigational Site, Eugene, Oregon 97401, United States
Pfizer Investigational Site, Portland, Oregon 97210, United States
Pfizer Investigational Site, Salem, Oregon 97301, United States
Pfizer Investigational Site, Media, Pennsylvania 19063, United States
Pfizer Investigational Site, Herndon, Virginia 20170, United States
Pfizer Investigational Site, Midlothian, Virginia 23112, United States
Pfizer Investigational Site, Middleton, Wisconsin 53562, United States
Pfizer Investigational Site, Waukesha, Wisconsin 53188, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2009
Last updated: April 7, 2011
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