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

NCT01371721

Last updated date
Study Location
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, 36303, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subject requires precaution against suicide


- Subject not in a generally healthy condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: DVS SR
Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Study Arms  ICMJE Experimental: Desvenlafaxine Succinate Sustained-Release
Intervention: Drug: DVS SR
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2016)
269
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
333
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01371721
Other Study ID Numbers  ICMJE B2061031
3151A6-3357 ( Other Identifier: Alias Study Number )
2008-002064-34 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP