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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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Related Links

MHRA Investigation into Glaxosmithkline/Seroxat

Paxil Study 329