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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: August 18, 2014
Last verified: August 2014
  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 Safety, Efficacy, And Tolerability Of DVS SR In 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 visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Improvement (CGI-I) score at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-S score change from baseline at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Harmonex Neuroscience Research, Inc. Recruiting
Dothan, Alabama, United States, 36303
United States, Arizona
Dedicated Clinical Research Recruiting
Goodyear, Arizona, United States, 85395
University of Arizona College of Medicine Dept of Psychiatry Recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Psychiatric Clinic Clinical Research Trials, P.A. Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
ATP Clinical Research, Incorporated Recruiting
Costa Mesa, California, United States, 92626
Behavioral Research Specialists, LLC Recruiting
Glendale, California, United States, 91206
Synergy Clinical Research Center Recruiting
National City, California, United States, 91950
Pacific Clinical Research Medical Group Recruiting
Orange, California, United States, 92868
Neuropsychiatric Research Center of Orange County Recruiting
Orange, California, United States, 92868
Sharp Mesa Vista Hospital Recruiting
San Diego, California, United States, 92123
PCSD - Feighner Research Not yet recruiting
San Diego, California, United States, 92108
Advantage Clinical Research Recruiting
Santa Ana, California, United States, 92701
Elite Clinical Trials, Incorporated Recruiting
Wildomar, California, United States, 92595
United States, Colorado
The Children's Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Amedica Research Institute, Incorporated Terminated
Hialeah, Florida, United States, 33013
Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32806
Winter Park Memorial Hospital Terminated
Winter Park, Florida, United States, 32792
Kolin Research Group Terminated
Winter Park, Florida, United States, 32789-3747
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30308
Institute for Behavioral Medicine, LLC Recruiting
Smyrna, Georgia, United States, 300806315
United States, Kansas
Psychiatric Associates Recruiting
Overland Park, Kansas, United States, 66211
United States, Louisiana
Lake Charles Clinical Trials, LLC Recruiting
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Neuroscientific Insights Terminated
Rockville, Maryland, United States, 20852
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
United States, Missouri
St. Charles Psychiatric Associates - Midwest Research Group Recruiting
St. Charles, Missouri, United States, 63301
Midwest Chest Consultants Recruiting
St. Charles, Missouri, United States, 63301
United States, Nebraska
Heartland Pharma Developments Terminated
North Platte, Nebraska, United States, 69101
Creighton University, Department of Psychiatry Recruiting
Omaha, Nebraska, United States, 68131
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Incorporated Recruiting
Las Vegas, Nevada, United States, 89128
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Nina F. Wimpie, MD Pediatrics Not yet recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Paradigm Research Professionals, LLC Recruiting
Edmond, Oklahoma, United States, 73013
Cutting Edge Research of Enid Recruiting
Enid, Oklahoma, United States, 73703
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network (Oregon), Incorporated Recruiting
Portland, Oregon, United States, 97210
United States, Tennessee
Clinical Neuroscience Solutions, Incorporated Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Focus & Balance, LLC Not yet recruiting
San Antonio, Texas, United States, 78229
Grayline Clinical Drug Trials Terminated
Witchita Falls, Texas, United States, 76309
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Summit Research Network (Seattle) LLC Recruiting
Seattle, Washington, United States, 98104
United States, Wisconsin
Rogers Center For Research And Training Recruiting
Milwaukee, Wisconsin, United States, 53227
Mexico
Hospital Aranda de la Parra S.A. de C.V. Recruiting
Leon, Guanajuato, Mexico, 37000
Hospital Aranda de la Parra Recruiting
Leon, Guanajuato, Mexico, 37000
CIT-Neuropsique, S.C. Recruiting
Monterrey, Nuevo Leoan, Mexico, 64610
Centro de Investigacion y Terapia CIT - Neuropsique Recruiting
Monterrey, Nuevo Leon, Mexico, 64020
Hospital Aranda de la Parra Recruiting
Leon, Mexico, 37000
Hospital Aranda de la Parra, S.A. de C.V._1 Recruiting
Mexico City, Mexico, 37000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01372150     History of Changes
Other Study ID Numbers: B2061014, 3151A6-3356
Study First Received: June 9, 2011
Last Updated: August 18, 2014
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
Fluoxetine
O-desmethylvenlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014