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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients 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 B2061032 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:

  • Requires precaution against suicide
  • Not in generally healthy medical condition
  • Poor compliance with study drug or study procedures during participation in study B2061032

Sites / Locations

  • The University Of Alabama At Birmingham, Office Of Psychiatric Research
  • Center for Advanced Improvement
  • Sun Valley Research Center
  • MCB Clinical Research Centers
  • Institute of Living/Hartford Hospital
  • 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
  • Baber Research Group
  • Clinco
  • Pharmasite Research, Inc
  • Millennium Psychiatric Associates, LLC
  • Premier Psychiatric Research Institute, LLC
  • Erie County Medical Center/State University of New York (SUNY) 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.
  • Clinical Trials of Texas, INC
  • Allance Research Group
  • Alliance Research Group
  • Virginia Commonwealth University
  • Virginia Treatment Center for Children
  • Eastside Therapeutic Resource
  • Biomedica Research Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Desvenlafaxine Succinate Sustained-Release

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.

Secondary Outcome Measures

Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.

Full Information

First Posted
June 9, 2011
Last Updated
June 28, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01371708
Brief Title
A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD
Official Title
A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 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
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2012 (Actual)
Primary Completion Date
April 22, 2016 (Actual)
Study Completion Date
April 22, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
283 (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 With a Treatment-emergent Adverse Event (TEAE)
Description
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
Description
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
Description
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
Description
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
Description
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
Description
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Title
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
Description
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
Time Frame
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

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 B2061032 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: Requires precaution against suicide Not in generally healthy medical condition Poor compliance with study drug or study procedures during participation in study B2061032
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
The University Of Alabama At Birmingham, Office Of Psychiatric Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0009
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
Institute of Living/Hartford Hospital
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
Baber Research Group
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
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 (SUNY) 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
Clinical Trials of Texas, INC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
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 for Children
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
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

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=B2061030&StudyName=A%206-Month%20Extension%20Study%20To%20The%20B2061032%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20And%20Efficacy%20Of%20DVS%20SR%20In%20The%20Treatment%20Of
Description
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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

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