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Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)

Depressive Disorder Clinical Trial

Official 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<Post-marketing Clinical Study>

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00812812
Study type Interventional
Source GlaxoSmithKline
Contact
Status Terminated
Phase Phase 4
Start date March 2009
Completion date February 2011
View Details
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