search
Back to results

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
Desvenlafaxine Succinate Sustained-Release
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 behavior or requires precaution against suicide
  • Not in generally healthy medical condition
  • History of psychosis or bipolar disorder
  • Seizure disorder

Sites / Locations

  • Children's Hospital of Alabama Laboratory
  • The University of Alabama at Birmingham, Office of Psychiatric Research
  • Center for Advanced Improvement
  • Sun Valley Research Center
  • MCB Clinical Research Centers
  • Bliss Basement Pharmacy - Hartford Hospital
  • Institute of Living/Hartford Hospital
  • Institute of Living
  • SJS Clinical Research, Inc.
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions
  • Medical Research Group of Central Florida
  • Millenia Psychiatry & Research, Inc.
  • Janus Center for Psychiatric Research
  • Northwest Behavioral Research Center
  • Capstone Clinical Research
  • AMR-Baber Research Inc.
  • Clinco
  • Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
  • Drug:University Health Shreveport Outpatient
  • Pharmasite Research Inc
  • Millennium Psychiatric Associates, LLC
  • Premier Psychiatric Research Institute, LLC
  • Erie County Medical Center / State University of New York at Buffalo affiliate
  • The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
  • Bioscience Research, LLC.
  • Finger Lakes Clinical Research
  • Stony Brook University Medical Center, Child And Adolescent Psychiatry
  • Neuro-Behavioral Clinical Research, Inc.
  • Discovery and Wellness Center for Children/University Hospitals Case Medical Center
  • Sooner Clinical Research
  • Research Strategies of Memphis, LLC.
  • FutureSearch Trials
  • Clinical Trials of Texas, Inc.
  • Alliance Research Group
  • Virginia Commonwealth University
  • Virginia Treatment Center
  • Carilion Medical Center
  • Eastside Therapeutic Resource
  • Biomedica Research Group
  • Optima Salud
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental Arm 1 - high dose

Experimental Arm 2 - low dose

Placebo Arm

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.

Secondary Outcome Measures

Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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 equals (=) 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) or 2 (much improved) on the scale. Higher score = more affected.

Full Information

First Posted
June 9, 2011
Last Updated
January 30, 2017
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01371734
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, 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 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 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 Sustained-Release (DVS SR) versus 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
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1 - high dose
Arm Type
Experimental
Arm Title
Experimental Arm 2 - low dose
Arm Type
Experimental
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release
Intervention Description
Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Succinate Sustained-Release
Intervention Description
Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects randomized to the Placebo treatment arm will receive placebo tablets
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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 (n=102, 105, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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 equals (=) more affected.
Time Frame
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) or 2 (much 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 behavior 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
Children's Hospital of Alabama Laboratory
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The University of Alabama at Birmingham, Office of Psychiatric Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Center for Advanced Improvement
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Facility Name
MCB Clinical Research Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Bliss Basement Pharmacy - Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
SJS Clinical Research, Inc.
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Millenia Psychiatry & Research, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32839
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
AMR-Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Drug:University Health Shreveport Outpatient
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Pharmasite Research Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Millennium Psychiatric Associates, LLC
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Erie County Medical Center / State University of New York at Buffalo affiliate
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Bioscience Research, LLC.
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Stony Brook University Medical Center, Child And Adolescent Psychiatry
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8790
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Discovery and Wellness Center for Children/University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Strategies of Memphis, LLC.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Alliance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Treatment Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Biomedica Research Group
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Optima Salud
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8320325
Country
Chile
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
064460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
29185786
Citation
Atkinson S, Lubaczewski S, Ramaker S, England RD, Wajsbrot DB, Abbas R, Findling RL. Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):55-65. doi: 10.1089/cap.2017.0099. Epub 2017 Nov 29.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061032&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

We'll reach out to this number within 24 hrs