A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372150
• Other study ID #: B2061014
• Secondary ID: 3151A6-33562008-
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2011
• Est. completion date: March 20, 2015

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: March 20, 2015
• Est. primary completion date: March 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• desvenlafaxine succinate sustained release
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.
• fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
• placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules

Locations

Country	Name	City	State
Mexico	Hospital Aranda de la Parra S.A. de C.V.	Leon	Guanajuato
Mexico	CIT - Neuropsique, S.C.	Monterrey	Nuevo LEON
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Cincinnati Children's Hospital Medical Center (New)	Cincinnati	Ohio
United States	ATP Clinical Research, Inc. 1	Costa Mesa	California
United States	Harmonex Neuroscience Research, Inc.	Dothan	Alabama
United States	Precise Research Centers	Flowood	Mississippi
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Amedica Research Institute, Incorporated	Hialeah	Florida
United States	Lake Charles Clinical Trials,	Lake Charles	Louisiana
United States	Center for Psychiatry and Behavioral Medicine, Incorporated	Las Vegas	Nevada
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Nina F. Wimpie, MD Pediatrics	Middleburg Heights	Ohio
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Rogers Center For Research And Training	Milwaukee	Wisconsin
United States	Synergy Clinical Research Center	National City	California
United States	Heartland Pharma Developments	North Platte	Nebraska
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals, LLC	Oklahoma City	Oklahoma
United States	Creighton University	Omaha	Nebraska
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Summit Research Network (Oregon), Incorporated	Portland	Oregon
United States	Neuroscientific Insights	Rockville	Maryland
United States	Midwest Research Group	Saint Charles	Missouri
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Focus & Balance, LLC	San Antonio	Texas
United States	Sharp Mesa Vista Hospital	San Diego	California
United States	Summit Research Network (Seattle) LLC	Seattle	Washington
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	University of Arizona Clinical and Translational Science Center (CATS)	Tucson	Arizona
United States	University of Arizona College of Medicine Dept of Psychiatry	Tucson	Arizona
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	Elite Clinical Trials, Incorporated	Wildomar	California
United States	Kolin Research Group	Winter Park	Florida
United States	Winter Park Memorial Hospital	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score	A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.	Baseline and Week 8
Secondary	Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Baseline and Weeks 1, 2, 3, 4, 6, and 8
Secondary	Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'	A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Weeks 1, 2, 3, 4, 6, and 8

External Links

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