Major Depressive Disorder Clinical Trial
Official title:
A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Verified date | July 2016 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 283 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR - Willingness and ability to comply with scheduled visits, treatment plan, and procedures Exclusion Criteria: - Requires precaution against suicide - Not in generally healthy medical condition - Poor compliance with study drug or study procedures during participation in study B2061032 |
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Biomedica Research Group | Santiago | Region Metropolitana |
United States | FutureSearch Trials | Austin | Texas |
United States | Pharmasite Research, Inc | Baltimore | Maryland |
United States | The University Of Alabama At Birmingham, Office Of Psychiatric Research | Birmingham | Alabama |
United States | Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate | Buffalo | 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 | MCB Clinical Research Centers | Colorado Springs | Colorado |
United States | Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri |
United States | SJS Clinical Research, Inc. | Destin | Florida |
United States | Sarkis Clinical Trials | Gainesville | Florida |
United States | The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System | Glen Oaks | New York |
United States | Institute of Living/Hartford Hospital | Hartford | Connecticut |
United States | Sun Valley Research Center | Imperial | California |
United States | Clinical Neuroscience Solutions | Jacksonville | Florida |
United States | Eastside Therapeutic Resource | Kirkland | Washington |
United States | Capstone Clinical Research | Libertyville | Illinois |
United States | Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska |
United States | Northwest Behavioral Research Center | Marietta | Georgia |
United States | Research Strategies of Memphis, LLC. | Memphis | Tennessee |
United States | Bioscience Research, LLC. | Mount Kisco | New York |
United States | Baber Research Group | Naperville | Illinois |
United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
United States | Medical Research Group of Central Florida | Orange City | Florida |
United States | Millenia Psychiatry & Research, Inc. | Orlando | Florida |
United States | Allance Research Group | Richmond | Virginia |
United States | Alliance Research Group | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Virginia Treatment Center for Children | Richmond | Virginia |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | Clinical Trials of Texas, Inc | San Antonio | Texas |
United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
United States | Stony Brook University Medical Center, child and Adolescent Psychiatry | Stony Brook | New York |
United States | Clinco | Terre Haute | Indiana |
United States | Center for Advanced Improvement | Tucson | Arizona |
United States | Janus Center for Psychiatric Research | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children's Depression Rating Scale, Revised (CDRS-R) total score change from baseline | up to 26 weeks | No | |
Secondary | Clinical Global Impression Improvement (CGI I) score | up to 26 weeks | No | |
Secondary | Clinical Global Impression Severity (CGI S) score change from baseline | up to 26 weeks | No | |
Secondary | CGI I response (score of 1 or 2) | up to 26 weeks | No | |
Secondary | Remission on the CDRS-R (score =28) | up to 26 weeks | No |
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