Overview

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

Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Paroxetine
Serotonin Uptake Inhibitors