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

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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.
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Smyrna, Georgia 30080
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1915 N Kavaney Drive
Bismarck, North Dakota 58501
701-250-7355
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901 Boren Avenue
Seattle, Washington 98104
206-624-4587
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5601 Corporate Way
West Palm Beach, Florida 33407
561-238-3036
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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Allentown, Pennsylvania 18104
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Baltimore, Maryland 21208
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Beachwood, Ohio 44122
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Beverly Hills, California 90210
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8043 Cooper Creek Boulevard Suite 107
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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Brooklyn, New York 11235
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Cedarhurst, New York 11516
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Cincinnati, Ohio 45242
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Columbia, South Carolina 29201
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Dallas, Texas 75231
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Dallas, Texas 75230
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Dallas, Texas 75231
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Escondido, California 92025
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Fargo, North Dakota 58104
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Fargo, North Dakota 58103
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Houston, Texas 17115
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Jacksonville, Florida 32216
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Joliet, Illinois 60435
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Kirkland, Washington 98033
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Kissimmee, Florida 34741
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Libertyville, Illinois 60048
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Lincoln, Rhode Island 02865
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Media, Pennsylvania 19063
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Murray, Utah 84123
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Naperville, Illinois 60563
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National City, California 91950
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New York, New York 10021
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New York, New York 10023
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North Platte, Nebraska 69101
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Oak Brook, Illinois 60523
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Oakland, California 94612
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Oklahoma City, Oklahoma 73116
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Orange, California 92868
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Overland Park, Kansas 66211
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Pasadena, California 91106
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Philadelphia, Pennsylvania 19139
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Phoenix, Arizona 85020
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Phoenix, Arizona 85020
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Portland, Oregon 97210
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San Diego, California 92108
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Santa Ana, California 92705
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St. Charles, Missouri 63301
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St. Petersburg, Florida 33716
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Temecula, California 92591
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Willingboro, New Jersey 08046
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