A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
NCT ID: NCT01372150
Last Updated: 2019-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2011-11-17
2015-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DVS SR
desvenlafaxine succinate sustained release
Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
Fluoxetine
Active control for assay sensitivity
fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Placebo
placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Interventions
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desvenlafaxine succinate sustained release
Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Eligibility Criteria
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Inclusion Criteria
* Primary diagnosis of major depressive disorder (MDD)
* CDRS-R score \>40
Exclusion Criteria
* Not in generally healthy medical condition
* History of psychosis or bipolar disorder
* Seizure disorder
7 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Harmonex Neuroscience Research, Inc.
Dothan, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
University of Arizona Clinical and Translational Science Center (CATS)
Tucson, Arizona, United States
University of Arizona College of Medicine Dept of Psychiatry
Tucson, Arizona, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
ATP Clinical Research, Inc. 1
Costa Mesa, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Synergy Clinical Research Center
National City, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Elite Clinical Trials, Incorporated
Wildomar, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Amedica Research Institute, Incorporated
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Winter Park Memorial Hospital
Winter Park, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Institute for Behavioral Medicine
Smyrna, Georgia, United States
Psychiatric Associates
Overland Park, Kansas, United States
Lake Charles Clinical Trials,
Lake Charles, Louisiana, United States
Neuroscientific Insights
Rockville, Maryland, United States
Precise Research Centers
Flowood, Mississippi, United States
Midwest Research Group
Saint Charles, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Heartland Pharma Developments
North Platte, Nebraska, United States
Creighton University
Omaha, Nebraska, United States
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, United States
Cincinnati Children's Hospital Medical Center (New)
Cincinnati, Ohio, United States
Nina F. Wimpie, MD Pediatrics
Middleburg Heights, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon), Incorporated
Portland, Oregon, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Focus & Balance, LLC
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, United States
Rogers Center For Research And Training
Milwaukee, Wisconsin, United States
Hospital Aranda de la Parra S.A. de C.V.
León, Guanajuato, Mexico
CIT - Neuropsique, S.C.
Monterrey, Nuevo León, Mexico
Countries
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Related Links
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Other Identifiers
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3151A6-3356
Identifier Type: OTHER
Identifier Source: secondary_id
2008-002063-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B2061014
Identifier Type: -
Identifier Source: org_study_id
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