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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, 36303 United States
Contact
1-800-718-1021
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

- Age >=7 and

- Primary diagnosis of major depressive disorder (MDD)

- CDRS-R score >40

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

- History of suicidal behaviour, or requires precaution against suicide

- Not in generally healthy medical condition

- History of psychosis or bipolar disorder

- Seizure disorder

NCT01372150
Pfizer
Completed
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

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Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Official Title  ICMJE A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER
Brief SummaryThis is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: desvenlafaxine succinate sustained release
    Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
  • Drug: fluoxetine
    Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
  • Drug: placebo
    Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
Study Arms  ICMJE
  • Experimental: DVS SR
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Fluoxetine
    Active control for assay sensitivity
    Intervention: Drug: fluoxetine
  • Experimental: Placebo
    Intervention: Drug: placebo
Publications *Not Provided


*   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: April 20, 2015)
340
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2011)
390
Actual Study Completion Date  ICMJE March 20, 2015
Actual Primary Completion DateMarch 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >=7 and <18 years of age
  • Primary diagnosis of major depressive disorder (MDD)
  • CDRS-R score >40

Exclusion Criteria:

  • History of suicidal behaviour, or requires precaution against suicide
  • Not in generally healthy medical condition
  • History of psychosis or bipolar disorder
  • Seizure disorder
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 NCT01372150
Other Study ID Numbers  ICMJE B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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