Clinical trial NCT01371708: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 283
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Secondary outcomes:
measure: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: 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)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: 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
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: 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)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: 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
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
measure: 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)
timeFrame: From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University Of Alabama At Birmingham, Office Of Psychiatric Research
state: Alabama
city: Tucson
country: United States
facility: Center for Advanced Improvement
state: Arizona
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
city: Destin
country: United States
facility: SJS Clinical Research, Inc.
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Millenia Psychiatry & Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc
state: Maryland
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Buffalo
country: United States
facility: Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
state: New York
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center, child and Adolescent Psychiatry
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Discovery and Wellness Center for Children/University Hospitals Case Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, INC
state: Texas
city: Richmond
country: United States
facility: Allance Research Group
state: Virginia
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: Virginia Treatment Center for Children
state: Virginia
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Santiago
country: Chile
facility: Biomedica Research Group
state: Region Metropolitana
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.