A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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
3 other identifiers
interventional
363
3 countries
42
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Aug 2011
Longer than P75 for phase_3 major-depressive-disorder
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
March 20, 2017
CompletedMarch 20, 2017
January 1, 2017
4.1 years
June 9, 2011
March 7, 2016
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.
Baseline and Week 8
Secondary Outcomes (3)
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
Baseline and Week 8
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Weeks 1, 2, 3, 4, 6, and 8
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Weeks 1, 2, 3, 4, 6, and 8
Study Arms (3)
Experimental Arm 1 - high dose
EXPERIMENTALExperimental Arm 2 - low dose
EXPERIMENTALPlacebo Arm
PLACEBO COMPARATORInterventions
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Eligibility Criteria
You may qualify if:
- Age \>=7 and \<18 years of age
- Primary diagnosis of major depressive disorder (MDD)
- CDRS-R score \>40
You may not qualify if:
- History of suicidal behavior or requires precaution against suicide
- Not in generally healthy medical condition
- History of psychosis or bipolar disorder
- Seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (42)
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
Colorado Springs, Colorado, 80910, United States
Bliss Basement Pharmacy - Hartford Hospital
Hartford, Connecticut, 06102, United States
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106, United States
Institute of Living
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
Jacksonville, Florida, 32256, 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
Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
Shreveport, Louisiana, 71103, United States
Drug:University Health Shreveport Outpatient
Shreveport, Louisiana, 71130, 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, Child And Adolescent Psychiatry
Stony Brook, New York, 11794-8790, United States
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
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 Medical Center
Roanoke, Virginia, 24014, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Biomedica Research Group
Santiago, Santiago Metropolitan, 7500710, Chile
Optima Salud
Santiago, Santiago Metropolitan, 8320325, Chile
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
Monterrey, Nuevo León, 064460, Mexico
Related Publications (1)
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.
PMID: 29185786DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 13, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 20, 2017
Results First Posted
March 20, 2017
Record last verified: 2017-01