A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
NCT ID: NCT01371734
Last Updated: 2017-03-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
363 participants
INTERVENTIONAL
2011-08-31
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
NCT01372150
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
NCT01371708
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
NCT01371721
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
NCT00669110
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
NCT01432457
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Arm 1 - high dose
Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Experimental Arm 2 - low dose
Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
Placebo Arm
Placebo
Subjects randomized to the Placebo treatment arm will receive placebo tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Desvenlafaxine Succinate Sustained-Release
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
Placebo
Subjects randomized to the Placebo treatment arm will receive placebo tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Alabama Laboratory
Birmingham, Alabama, United States
The University of Alabama at Birmingham, Office of Psychiatric Research
Birmingham, Alabama, United States
Center for Advanced Improvement
Tucson, Arizona, United States
Sun Valley Research Center
Imperial, California, United States
MCB Clinical Research Centers
Colorado Springs, Colorado, United States
Bliss Basement Pharmacy - Hartford Hospital
Hartford, Connecticut, United States
Institute of Living/Hartford Hospital
Hartford, Connecticut, United States
Institute of Living
Hartford, Connecticut, United States
SJS Clinical Research, Inc.
Destin, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Millenia Psychiatry & Research, Inc.
Orlando, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
Capstone Clinical Research
Libertyville, Illinois, United States
AMR-Baber Research Inc.
Naperville, Illinois, United States
Clinco
Terre Haute, Indiana, United States
Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
Shreveport, Louisiana, United States
Drug:University Health Shreveport Outpatient
Shreveport, Louisiana, United States
Pharmasite Research Inc
Baltimore, Maryland, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
Erie County Medical Center / State University of New York at Buffalo affiliate
Buffalo, New York, United States
The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
Glen Oaks, New York, United States
Bioscience Research, LLC.
Mount Kisco, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Stony Brook University Medical Center, Child And Adolescent Psychiatry
Stony Brook, New York, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Discovery and Wellness Center for Children/University Hospitals Case Medical Center
Cleveland, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Research Strategies of Memphis, LLC.
Memphis, Tennessee, United States
FutureSearch Trials
Austin, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Alliance Research Group
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Virginia Treatment Center
Richmond, Virginia, United States
Carilion Medical Center
Roanoke, Virginia, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Biomedica Research Group
Santiago, Santiago Metropolitan, Chile
Optima Salud
Santiago, Santiago Metropolitan, Chile
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
Monterrey, Nuevo León, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3151A6-3343
Identifier Type: OTHER
Identifier Source: secondary_id
2008-001875-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B2061032
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.