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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371708
• Other study ID #: B2061030
• Secondary ID: 3151A6-33442008-
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2011
• Last updated: July 5, 2016
• Start date: February 2012
• Est. completion date: April 2016

Study information

• Verified date: July 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: 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

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
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Chile, 

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	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

External Links

•   To obtain contact information for a study center near you, click here.