Clinical trial NCT01371734: A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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 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: 363
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 Sustained-Release (DVS SR) versus 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 behavior 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 (n=102, 104, 106)
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
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: 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: Birmingham
country: United States
facility: Children's Hospital of Alabama Laboratory
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham, Office of Psychiatric Research
state: Alabama
city: Tucson
country: United States
facility: Center for Advanced Improvement
state: Arizona
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Hartford
country: United States
facility: Bliss Basement Pharmacy - Hartford Hospital
state: Connecticut
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Millenia Psychiatry & Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
state: Louisiana
city: Shreveport
country: United States
facility: Drug:University Health Shreveport Outpatient
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research Inc
state: Maryland
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Buffalo
country: United States
facility: Erie County Medical Center / State University of New York at Buffalo affiliate
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center, Child And Adolescent Psychiatry
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Discovery and Wellness Center for Children/University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: Virginia Treatment Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Santiago
country: Chile
facility: Biomedica Research Group
state: Region Metropolitana
city: Santiago
country: Chile
facility: Optima Salud
state: Region Metropolitana
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
state: Nuevo Leon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.