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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

Page last updated: August 23, 2015

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