You are here

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
Children's Hospital of Alabama Laboratory
Birmingham, Alabama, 35233 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 behavior or requires precaution against suicide

- Not in generally healthy medical condition

- History of psychosis or bipolar disorder

- Seizure disorder

NCT01371734
Pfizer
Completed
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Obsessive Compulsive Disorder
NCT01302080
All Genders
6+
Years
Multiple Sites
Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
A Multicenter, Randomized, Double-blind, Placebo-controlled, 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 Sustained-Release (DVS SR) versus 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 treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
  • Drug: Desvenlafaxine Succinate Sustained-Release
    Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
  • Drug: Placebo
    Subjects randomized to the Placebo treatment arm will receive placebo tablets
  • Experimental: Experimental Arm 1 - high dose
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release
  • Experimental: Experimental Arm 2 - low dose
    Intervention: Drug: Desvenlafaxine Succinate Sustained-Release
  • Placebo Comparator: Placebo Arm
    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
363
September 2015
September 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 behavior 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
Chile,   Mexico,   United States
Puerto Rico
 
NCT01371734
B2061032
3151A6-3343 ( Other Identifier: Alias Study Number )
2008-001875-32 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now