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A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DVS SR
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:

  • Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR
  • Willingness and ability to comply with scheduled visits, treatment plan and procedures

Exclusion Criteria:

  • Subject requires precaution against suicide
  • Subject not in a generally healthy condition

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, Incorporated
  • Behavioral Research Specialists, LLC
  • Synergy Clinical Research Center
  • Neuropsychiatric Research Center of Orange County
  • Pacific Clinical Research Medical Group
  • Elite Clinical Trials, Incorporated
  • Children's Hospital Colorado
  • Amedica Research Institute, Incorporated
  • Clinical Neuroscience Solutions, Inc.
  • Kolin Research Group
  • Atlanta Center for Medical Research
  • Institute for Behavioral Medicine, LLC
  • Psychiatric Associates
  • Lake Charles Clinical Trials,
  • Precise Research Centers
  • St. Charles Psychiatric Associates - Midwest Research Group
  • Center for Psychiatry and Behavioral Medicine, Incorporated
  • 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, Incorporated
  • Hospital Aranda de la Parra, S.A. de C.V.
  • CIT-Neuropsique, S.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desvenlafaxine Succinate Sustained-Release

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing a Treatment Emergent Adverse Event

Secondary Outcome Measures

Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
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.
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
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 With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
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.
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
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
December 16, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01371721
Brief Title
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Official Title
A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 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 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate sustained release (DVS SR) in the treatment of child 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
Masking
None (Open Label)
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desvenlafaxine Succinate Sustained-Release
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DVS SR
Intervention Description
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing a Treatment Emergent Adverse Event
Time Frame
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Secondary Outcome Measure Information:
Title
Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
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
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Title
Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
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
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Title
Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26
Description
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time Frame
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Title
Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
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
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Title
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
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
Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study

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: Completed study B2061014 and who in the investigator's opinion would benefit from long term treatment with DVS SR Willingness and ability to comply with scheduled visits, treatment plan and procedures Exclusion Criteria: Subject requires precaution against suicide Subject not in a generally healthy condition
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, Incorporated
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
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
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Institute for Behavioral Medicine, LLC
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
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
St. Charles Psychiatric Associates - Midwest Research Group
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63303
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
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
Witchita 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, Incorporated
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
64010
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
30419989
Citation
Atkinson S, Thurman L, Ramaker S, Buckley G, Jones SR, England R, Wajsbrot D. Safety, Tolerability, and Efficacy of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder: Results from Two Open-Label Extension Trials. CNS Spectr. 2019 Oct;24(5):496-506. doi: 10.1017/S1092852918001128.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061031&StudyName=A%206-Month%20Open-Label%20Extension%20Study%20to%20the%20B2061014%20Study%20to%20Evaluate%20the%20Safety%2C%20Tolerability%20and%20Efficacy%20of%20DVS%20SR%20in%20the%20Trea
Description
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Learn more about this trial

A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD

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