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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Desvenlafaxine Succinate Sustained-Release (Drug); Desvenlafaxine Succinate Sustained-Release (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).

Clinical Details

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline to Week 8 in the Child Depression Rating Scale - Revised (CDRS-R): Total Score

Secondary outcome:

Clinical Global Impression Improvement (CGI-I) Score at the Week 8 visit

Clinical Global Impression Severity Score at the Week 8 visit

Clinical Global Impression Improvement Response (score 1 or 2)

Eligibility

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age >=7 and <18 years of age

- Primary diagnosis of major depressive disorder (MDD)

- CDRS-R score >40

Exclusion Criteria:

- History of suicidal behavior or requires precaution against suicide

- Not in generally healthy medical condition

- History of psychosis or bipolar disorder

- Seizure disorder

Locations and Contacts

Children's Hospital of Alabama Laboratory, Birmingham, Alabama 35233, United States

The University of Alabama at Birmingham, Office of Psychiatric Research, Birmingham, Alabama 35294, United States

Center for Advanced Improvement, Tucson, Arizona 85719, United States

Sun Valley Research Center, Imperial, California 92251, United States

MCB Clinical Research Centers, LLC, Colorado Springs, Colorado 80910, United States

Bliss Basement Pharmacy - Hartford Hospital, Hartford, Connecticut 06102, United States

Institute of Living, Hartford, Connecticut 06106, United States

Institute of Living/Hartford Hospital, Hartford, Connecticut 06106, United States

SJS Clinical Research, Inc., Destin, Florida 32541, United States

Sarkis Clinical Trials, Gainesville, Florida 32607, United States

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida 32216, United States

Medical Research Group of Central Florida, Orange City, Florida 32763, United States

Millenia Psychiatry & Research, Inc., Orlando, Florida 32839, United States

Janus Center for Psychiatric Research, West Palm Beach, Florida 33407, United States

Northwest Behavioral Research Center, Marietta, Georgia 30060, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

AMR-Baber Research Inc., Naperville, Illinois 60563, United States

Clinco, Terre Haute, Indiana 47802, United States

Pharmasite Research Inc, Baltimore, Maryland 21208, United States

Millennium Psychiatric Associates, LLC, Creve Coeur, Missouri 63141, United States

Premier Psychiatric Research Institute, LLC, Lincoln, Nebraska 68526, United States

Erie County Medical Center / State University of New York at Buffalo affiliate, Buffalo, New York 14215, United States

The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Glen Oaks, New York 11004, United States

Bioscience Research, LLC., Mount Kisco, New York 10549, United States

Finger Lakes Clinical Research, Rochester, New York 14618, United States

Stony Brook University Medical Center, Stony Brook, New York 11794-8790, United States

Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria, Monterrey, Nuevo Leon 064460, Mexico

Neuro-Behavioral Clinical Research, Inc., Canton, Ohio 44718, United States

Discovery and Wellness Center for Children/University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States

Sooner Clinical Research, Oklahoma City, Oklahoma 73112, United States

Biomedica Research Group, Santiago, Region Metropolitana 7500710, Chile

Optima Salud, Santiago, Region Metropolitana 8320325, Chile

Research Strategies of Memphis, LLC., Memphis, Tennessee 38119, United States

FutureSearch Trials, Austin, Texas 78731, United States

Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States

Alliance Research Group, Richmond, Virginia 23230, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Virginia Treatment Center, Richmond, Virginia 23298, United States

Carilion Clinic, Roanoke, Virginia 24014, United States

Eastside Therapeutic Resource, Kirkland, Washington 98033, United States

Additional Information

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

Starting date: August 2011
Last updated: August 12, 2015

Page last updated: August 23, 2015

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