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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); fluoxetine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

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 (DVS SR) Sustained Release vs 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, Fluoxetine-referenced, 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 visit in the Children's depression rating scale, revised (CDRS-R) total score

Secondary outcome:

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

CGI-S score change from baseline at the Week 8 visit

CGI-I response (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 behaviour, or requires precaution against suicide

- Not in generally healthy medical condition

- History of psychosis or bipolar disorder

- Seizure disorder

Locations and Contacts

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

Sharp Mesa Vista Hospital, San Diego, California 92123, United States

Elite Clinical Trials, Incorporated, Wildomar, California 92595, United States

Children's Hospital Colorado, Aurora, Colorado 80045, United States

Children's Hospital Colorado (Clinical Site Address), Aurora, Colorado 80045, United States

Children's Hospital Colorado (Drug Ship Address), 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

Winter Park Memorial Hospital, Winter Park, Florida 32792, United States

Atlanta Center for Medical Research, Atlanta, Georgia 30331, United States

Institute for Behavioral Medicine, LLC, Smyrna, Georgia 30080, United States

Hospital Aranda de la Parra, Leon, Guanajuato 37000, Mexico

Psychiatric Associates, Overland Park, Kansas 66211, United States

Lake Charles Clinical Trials,, Lake Charles, Louisiana 70629, United States

Neuroscientific Insights, Rockville, Maryland 20852, United States

Precise Research Centers, Flowood, Mississippi 39232, United States

Midwest Research Group, St. Charles, Missouri 63304, United States

St. Charles Psychiatric Assocaites - Midwest Research Group, St.Charles, Missouri 63304, United States

Heartland Pharma Developments, North Platte, Nebraska 69101, United States

Creighton University, Omaha, Nebraska 68131, United States

Center for Psychiatry and Behavioral Medicine, Incorporated, Las Vegas, Nevada 89128, United States

CIT-Neuropsique, S.C., Monterrey, Nuevo Leoan 64610, Mexico

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States

Nina F. Wimpie, MD Pediatrics, Middleburg Heights, Ohio 44130, United States

North Star Medical Research, LLC, Middleburg Heights, Ohio 44130, United States

Cutting Edge Research of Enid, Enid, Oklahoma 73703, United States

IPS Research Company, Oklahoma City, Oklahoma 73103, 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

Clinical Neuroscience Solutions, Incorporated, 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, Milwaukee, Wisconsin 53227, United States

Additional Information

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

Starting date: November 2011
Last updated: April 29, 2015

Page last updated: August 23, 2015

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