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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371721
• Other study ID #: B2061031
• Secondary ID: 3151A6-33572008-
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2011
• Last updated: January 25, 2016
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject requires precaution against suicide

• Subject not in a generally healthy condition

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• DVS SR
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.

Locations

Country	Name	City	State
Mexico	Hospital Aranda de la Parra, S.A. de C.V.	Leon	Guanajuato
Mexico	CIT - Neuropsique, S.C.	Monterrey	Nuevo Leon
Mexico	CIT-Neuropsique, S.C.	Monterrey	Nuevo Leon
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	ATP Clinical Research, Incorporated	Costa Mesa	California
United States	Harmonex Neuroscience Research, Inc.	Dothan	Alabama
United States	Precise Research Centers	Flowood	Mississippi
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Amedica Research Institute, Incorporated	Hialeah	Florida
United States	Lake Charles Clinical Trials,	Lake Charles	Louisiana
United States	Center for Psychiatry and Behavioral Medicine, Incorporated	Las Vegas	Nevada
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Rogers Center for Research and Training, Incorporated	Milwaukee	Wisconsin
United States	Synergy Clinical Research Center	National City	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals, LLC	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Summit Research Network (Oregon), Incorporated	Portland	Oregon
United States	Biomedical Systems, Incorporated	Saint Louis	Missouri
United States	Focus & Balance, LLC	San Antonio	Texas
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Institute for Behavioral Medicine, LLC	Smyrna	Georgia
United States	St. Charles Psychiatric Associates - Midwest Research Group	St. Charles	Missouri
United States	Biomedical Systems, Inc.	St. Louis	Missouri
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	Elite Clinical Trials, Incorporated	Wildomar	California
United States	Kolin Research Group	Winter Park	Florida
United States	Grayline Clinical Drug Trials	Witchita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

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	Clinical Global Impression - Improvement (CGI-I) response (score of 1 or 2)		up to 26 weeks	No
Secondary	Remission on the Children's Depression Rating Scale, Revised (CDRS-R) (score <=28)		up to 26 weeks	No

External Links

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