Protocol Summary for 112487
Protocol Id: 112487
Secondary Ids: N/A
Title: A randomised, double-blind, placebo controlled, parallel group , flexible dose study to evaluate the efficacy and safety of Paxil® Tablets in children and adolescents with Major Depressive Disorder.
Phase: Phase 4
FDA Regulated Intervention? No
Study Type: interventional
Oversight Authority: Japan: Ministry of Health, Labour and Welfare
Brief Summary: This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes: To compare the efficacy of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD based on the change from baseline to Week 8/end-of-study in the CDRS-R total score no 8 weeks.
Secondary Outcomes: To compare the safety of paroxetine versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with MDD no 8 weeks.
To assess the plasma concentrations of paroxetine administered orally at Week 8 or withdrawal in subjects with MDD. no 8 weeks.
Conditions: Major Depressive Disorder
Keywords:
children and adolescents
paroxetine
CDRS-R
selective serotonin reuptake inhibitor
Gender: Both
Minimum Age: 7 years
Maximum Age: 17 years
Central Contact: US GSK Clinical Trials Call Center
Central Contact Email: info@clinicaltrialsforgsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Responsible Party Organization: GSK
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
Related Links
MHRA Investigation into Glaxosmithkline/Seroxat
Paxil Study 329
