Clinical trial NCT01372150: A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: major depressive disorder
MDD
depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 340
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
timeFrame: Baseline and Week 8
measure: Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
timeFrame: Baseline and Weeks 1, 2, 3, 4, 6, and 8
measure: Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
timeFrame: Weeks 1, 2, 3, 4, 6, and 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc.
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Clinical and Translational Science Center (CATS)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona College of Medicine Dept of Psychiatry
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc. 1
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Incorporated
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hialeah
country: United States
facility: Amedica Research Institute, Incorporated
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Winter Park
country: United States
facility: Winter Park Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials,
state: Louisiana
city: Rockville
country: United States
facility: Neuroscientific Insights
state: Maryland
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: North Platte
country: United States
facility: Heartland Pharma Developments
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Incorporated
state: Nevada
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center (New)
state: Ohio
city: Middleburg Heights
country: United States
facility: Nina F. Wimpie, MD Pediatrics
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon), Incorporated
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: San Antonio
country: United States
facility: Focus & Balance, LLC
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Milwaukee
country: United States
facility: Rogers Center For Research And Training
state: Wisconsin
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra S.A. de C.V.
state: Guanajuato
city: Monterrey
country: Mexico
facility: CIT - Neuropsique, S.C.
state: Nuevo LEON
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: