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NCT01376271 Clinical Trial

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

Social Phobia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376271
Other study ID # 114102
Secondary ID
Status Completed
Phase N/A
First received June 9, 2011
Last updated June 30, 2014
Start date January 2010
Est. completion date September 2013

Study information
Verified date June 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Paroxetine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets 1 year Yes
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