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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: desvenlafaxine succinate sustained release; Drug: fluoxetine; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Placebo	Drug: placebo; Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
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.
OTHER: Fluoxetine; Active control for assay sensitivity	Drug: fluoxetine; Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2011
• Primary Completion (ACTUAL): March 20, 2015
• Study Completion (ACTUAL): March 20, 2015

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (ESTIMATE): June 13, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: depression; MDD; major depressive disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Desvenlafaxine Succinate; Fluoxetine
• Other Study ID Numbers: B2061014; 3151A6-3356 (OTHER: Alias Study Number); 2008-002063-13 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.