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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Tuesday, July 21, 2009

Any News on the Paxil Kids Yet?




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

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