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
A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 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
3 other identifiers
interventional
269
2 countries
35
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Feb 2012
Longer than P75 for phase_3 major-depressive-disorder
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
February 8, 2017
CompletedFebruary 8, 2017
December 1, 2016
3.7 years
June 9, 2011
April 19, 2016
December 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing a Treatment Emergent Adverse Event
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Secondary Outcomes (5)
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Study Arms (1)
Desvenlafaxine Succinate Sustained-Release
EXPERIMENTALInterventions
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Eligibility Criteria
You may qualify if:
- Completed study B2061014 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
You may not qualify if:
- Subject requires precaution against suicide
- Subject not in a generally healthy condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (35)
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, 36303, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
University of Arizona Clinical and Translational Science Center (CATS)
Tucson, Arizona, 85724, United States
University of Arizona College of Medicine Dept of Psychiatry
Tucson, Arizona, 85724, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72211, United States
ATP Clinical Research, Incorporated
Costa Mesa, California, 92626, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Neuropsychiatric Research Center of Orange County
Orange, California, 92868, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
Elite Clinical Trials, Incorporated
Wildomar, California, 92595, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Amedica Research Institute, Incorporated
Hialeah, Florida, 33013, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Kolin Research Group
Winter Park, Florida, 32789-3747, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, 30080, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Lake Charles Clinical Trials,
Lake Charles, Louisiana, 70629, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63303, United States
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, 89128, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118, United States
Summit Research Network (Oregon), Incorporated
Portland, Oregon, 97210, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Focus & Balance, LLC
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Witchita Falls, Texas, 76309, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Rogers Center for Research and Training, Incorporated
Milwaukee, Wisconsin, 53227, United States
Hospital Aranda de la Parra, S.A. de C.V.
León, Guanajuato, 37000, Mexico
CIT-Neuropsique, S.C.
Monterrey, Nuevo León, 64010, Mexico
Related Publications (1)
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.
PMID: 30419989DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 13, 2011
Study Start
February 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 8, 2017
Results First Posted
February 8, 2017
Record last verified: 2016-12