A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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
3 other identifiers
interventional
340
2 countries
43
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).
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 Nov 2011
Longer than P75 for phase_3 major-depressive-disorder
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2015
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedJanuary 15, 2019
January 1, 2019
3.3 years
June 9, 2011
October 19, 2015
January 2, 2019
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
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. Adjusted mean presented.
Baseline and Week 8
Secondary Outcomes (3)
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
Baseline and Week 8
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Baseline and 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)
DVS SR
EXPERIMENTALFluoxetine
OTHERActive control for assay sensitivity
Placebo
EXPERIMENTALInterventions
Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
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 behaviour, 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 (43)
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, Inc. 1
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
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
Smyrna, Georgia, 30080, United States
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
Saint Charles, Missouri, 63304, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint 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
Cincinnati Children's Hospital Medical Center (New)
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
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, 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
Focus & Balance, LLC
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita 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
Hospital Aranda de la Parra S.A. de C.V.
León, Guanajuato, 37000, Mexico
CIT - Neuropsique, S.C.
Monterrey, Nuevo León, 64610, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
November 17, 2011
Primary Completion
March 20, 2015
Study Completion
March 20, 2015
Last Updated
January 15, 2019
Results First Posted
November 20, 2015
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.