MedTrace Logo

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

NCT00812812 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-01-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Depressive Disorder

Interventions

DRUG

paroxetine 10mg tablet

1 or 2 tablet(s) once a day

DRUG

paroxetine 20mg tablet

1 tablet once a day

DRUG

matched placebo to paroxetine 10mg

2 tablets once a day

DRUG

matched placebo to paroxetine 20mg

1 tablet once a day

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812812 on ClinicalTrials.gov