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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
desvenlafaxine succinate sustained release
fluoxetine
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, MDD, depression

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harmonex Neuroscience Research, Inc.
  • Dedicated Clinical Research
  • University of Arizona Clinical and Translational Science Center (CATS)
  • University of Arizona College of Medicine Dept of Psychiatry
  • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
  • ATP Clinical Research, Inc. 1
  • Behavioral Research Specialists, LLC
  • Synergy Clinical Research Center
  • Neuropsychiatric Research Center of Orange County
  • Pacific Clinical Research Medical Group
  • Sharp Mesa Vista Hospital
  • Elite Clinical Trials, Incorporated
  • Children's Hospital Colorado
  • Amedica Research Institute, Incorporated
  • Clinical Neuroscience Solutions, Inc.
  • Kolin Research Group
  • Winter Park Memorial Hospital
  • Atlanta Center for Medical Research
  • Institute for Behavioral Medicine
  • Psychiatric Associates
  • Lake Charles Clinical Trials,
  • Neuroscientific Insights
  • Precise Research Centers
  • Midwest Research Group
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Heartland Pharma Developments
  • Creighton University
  • Center for Psychiatry and Behavioral Medicine, Incorporated
  • Cincinnati Children's Hospital Medical Center (New)
  • Nina F. Wimpie, MD Pediatrics
  • North Star Medical Research, LLC
  • IPS Research Company
  • Cutting Edge Research Group
  • Paradigm Research Professionals, LLC
  • Summit Research Network (Oregon), Incorporated
  • Clinical Neuroscience Solutions, Inc
  • Focus & Balance, LLC
  • Grayline Clinical Drug Trials
  • Northwest Clinical Research Center
  • Summit Research Network (Seattle) LLC
  • Rogers Center For Research And Training
  • Hospital Aranda de la Parra S.A. de C.V.
  • CIT - Neuropsique, S.C.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

DVS SR

Fluoxetine

Placebo

Arm Description

Active control for assay sensitivity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 9, 2011
Last Updated
January 2, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01372150
Brief Title
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2011 (Actual)
Primary Completion Date
March 20, 2015 (Actual)
Study Completion Date
March 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, MDD, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVS SR
Arm Type
Experimental
Arm Title
Fluoxetine
Arm Type
Other
Arm Description
Active control for assay sensitivity
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Intervention Description
Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
Description
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.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
Description
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.
Time Frame
Baseline and Week 8
Title
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Description
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.
Time Frame
Baseline and Weeks 1, 2, 3, 4, 6, and 8
Title
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Description
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.
Time Frame
Weeks 1, 2, 3, 4, 6, and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex Neuroscience Research, Inc.
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Dedicated Clinical Research
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
University of Arizona Clinical and Translational Science Center (CATS)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arizona College of Medicine Dept of Psychiatry
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
ATP Clinical Research, Inc. 1
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Synergy Clinical Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Elite Clinical Trials, Incorporated
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Amedica Research Institute, Incorporated
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Kolin Research Group
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789-3747
Country
United States
Facility Name
Winter Park Memorial Hospital
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Lake Charles Clinical Trials,
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Neuroscientific Insights
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Heartland Pharma Developments
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Incorporated
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center (New)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nina F. Wimpie, MD Pediatrics
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Summit Research Network (Oregon), Incorporated
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Focus & Balance, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Summit Research Network (Seattle) LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Rogers Center For Research And Training
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Hospital Aranda de la Parra S.A. de C.V.
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
CIT - Neuropsique, S.C.
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64610
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061014&StudyName=A%20Study%20Of%20DVS%20SR%20In%20Treatment%20Of%20Children%20And%20Adolescent%20Outpatients%20With%20MDD
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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