A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
NCT ID: NCT01371721
Last Updated: 2017-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2012-02-29
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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Desvenlafaxine Succinate Sustained-Release
DVS SR
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Interventions
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DVS SR
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to comply with scheduled visits, treatment plan and procedures
Exclusion Criteria
* Subject not in a generally healthy condition
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, Incorporated
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
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
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, United States
Psychiatric Associates
Overland Park, Kansas, United States
Lake Charles Clinical Trials,
Lake Charles, Louisiana, United States
Precise Research Centers
Flowood, Mississippi, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, 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
Witchita 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, Incorporated
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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References
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Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3151A6-3357
Identifier Type: OTHER
Identifier Source: secondary_id
2008-002064-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B2061031
Identifier Type: -
Identifier Source: org_study_id
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