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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention Phase
Major Depressive Disorder
Drug: desvenlafaxine succinate sustained release
Drug: fluoxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 340
Study Start Date: November 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVS SR 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
Active control for assay sensitivity
Drug: fluoxetine
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Experimental: Placebo Drug: placebo
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372150

  Hide Study Locations
Locations
United States, Alabama
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, United States, 36303
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
University of Arizona Clinical and Translational Science Center (CATS)
Tucson, Arizona, United States, 85724
University of Arizona College of Medicine Dept of Psychiatry
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States, 72211
United States, California
ATP Clinical Research, Inc. 1
Costa Mesa, California, United States, 92626
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Synergy Clinical Research Center
National City, California, United States, 91950
Neuropsychiatric Research Center of Orange County
Orange, California, United States, 92868
Pacific Clinical Research Medical Group
Orange, California, United States, 92868
Sharp Mesa Vista Hospital
San Diego, California, United States, 92123
Elite Clinical Trials, Incorporated
Wildomar, California, United States, 92595
United States, Colorado
Children's Hospital Colorado (Drug Shipment Address)
Aurora, Colorado, United States, 80045
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Amedica Research Institute, Incorporated
Hialeah, Florida, United States, 33013
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Kolin Research Group
Winter Park, Florida, United States, 32789-3747
Winter Park Memorial Hospital
Winter Park, Florida, United States, 32792
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Institute for Behavioral Medicine
Smyrna, Georgia, United States, 30080
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
United States, Louisiana
Lake Charles Clinical Trials,
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Neuroscientific Insights
Rockville, Maryland, United States, 20852
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
Midwest Research Group
St. Charles, Missouri, United States, 63304
St. Charles Psychiatric Associates - Midwest Research Group
St.Charles, Missouri, United States, 63304
United States, Nebraska
Heartland Pharma Developments
North Platte, Nebraska, United States, 69101
Creighton University
Omaha, Nebraska, United States, 68131
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, United States, 89128
United States, Ohio
Cincinnati Children's Hospital Medical Center (New)
Cincinnati, Ohio, United States, 45229
Nina F. Wimpie, MD Pediatrics
Middleburg Heights, Ohio, United States, 44130
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
Summit Research Network (Oregon), Incorporated
Portland, Oregon, United States, 97210
United States, Tennessee
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
United States, Texas
Focus & Balance, LLC
San Antonio, Texas, United States, 78229
Grayline Clinical Drug Trials
Witchita Falls, Texas, United States, 76309
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle) LLC
Seattle, Washington, United States, 98104
United States, Wisconsin
Rogers Center For Research And Training
Milwaukee, Wisconsin, United States, 53227
Mexico
Hospital Aranda de la Parra S.A. de C.V.
Leon, Guanajuato, Mexico, 37000
CIT - Neuropsique, S.C.
Monterrey, Nuevo Leon, Mexico, 64610
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01372150     History of Changes
Other Study ID Numbers: B2061014  3151A6-3356  2008-002063-13 
Study First Received: June 9, 2011
Results First Received: October 19, 2015
Last Updated: April 29, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
major depressive disorder
MDD
depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Fluoxetine
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016