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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372150
First received: June 9, 2011
Last updated: April 29, 2016
Last verified: April 2016

June 9, 2011
April 29, 2016
November 2011
March 2015   (Final data collection date for primary outcome measure)
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score [ Time Frame: Baseline and Week 8 ]
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Change from baseline to final on-therapy visit in the Children's depression rating scale, revised (CDRS-R) total score [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01372150 on ClinicalTrials.gov Archive Site
  • Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Baseline and Week 8 ]
    A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
  • Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 [ Time Frame: Baseline and Weeks 1, 2, 3, 4, 6, and 8 ]
    A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
  • Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' [ Time Frame: Weeks 1, 2, 3, 4, 6, and 8 ]
    A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
  • Clinical Global Impression Improvement (CGI-I) score at the final on-therapy visit [ Time Frame: 8 weeks ]
  • CGI-S score change from baseline at the final on-therapy visit [ Time Frame: 8 weeks ]
  • CGI-I response (1 or 2) [ Time Frame: 8 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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
United States,   Mexico
 
 
NCT01372150
B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
Yes
Not Provided
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