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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01376271
Enrollment
600
Registered
2011-06-20
Start date
2010-01-31
Completion date
2013-09-30
Last updated
2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Phobia

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.

Interventions

DRUGParoxetine

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026