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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: October 1, 2014
Last verified: October 2014

June 9, 2011
October 1, 2014
November 2011
August 2016   (final data collection date for primary outcome measure)
Change from baseline to Week 8 visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to final on-therapy visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01372150 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression Improvement (CGI-I) score at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-S score change from baseline at the Week 8 visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-S score change from baseline at the final on-therapy visit [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
390
August 2016
August 2016   (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
Both
7 Years to 17 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Mexico
 
NCT01372150
B2061014, 3151A6-3356, 2008-002063-13
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

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