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

Last updated on May 10, 2018

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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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
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
This 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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • 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
  • Experimental: DVS SR
    Intervention: Drug: desvenlafaxine succinate sustained release
  • Fluoxetine
    Active control for assay sensitivity
    Intervention: Drug: fluoxetine
  • Experimental: Placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States
 
 
NCT01372150
B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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