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

GlaxoSmithKline600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Social Phobia

Interventions

ParoxetineDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets

Time frame: 1 year

Data from ClinicalTrials.gov

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