Clinical trial NCT01371721: 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
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: 269
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
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 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

Primary outcomes:
measure: Percentage of Participants Experiencing a Treatment Emergent Adverse Event
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Secondary outcomes:
measure: Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
measure: Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
measure: 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
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
measure: Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
measure: Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases
timeFrame: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research, Inc.
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Clinical and Translational Science Center (CATS)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona College of Medicine Dept of Psychiatry
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Incorporated
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Incorporated
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Hialeah
country: United States
facility: Amedica Research Institute, Incorporated
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine, LLC
state: Georgia
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials,
state: Louisiana
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Incorporated
state: Nevada
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon), Incorporated
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: San Antonio
country: United States
facility: Focus & Balance, LLC
state: Texas
city: Witchita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Milwaukee
country: United States
facility: Rogers Center for Research and Training, Incorporated
state: Wisconsin
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra, S.A. de C.V.
state: Guanajuato
city: Monterrey
country: Mexico
facility: CIT-Neuropsique, S.C.
state: Nuevo Leon
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.