Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Completed

• Conditions: Social Phobia
• Interventions: Drug: Paroxetine

• Registration Number: NCT01376271
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Subjects who are diagnosed as having SAD
• Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria

• Subjects taking pimozide
• Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
• Subjects with hypersensitivity to paroxetine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed paroxetine tablets	Paroxetine	Subjects with SAD prescribed paroxetine tablets during study period

Primary Outcome Measures

Name	Time	Method
The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets	1 year