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

June 30, 2014 updated by: GlaxoSmithKline
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All subjects diagnosed as having social anxiety disorder (SAD) are to be given paroxetine tablets according to the prescribing information

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects prescribed paroxetine tablets
Subjects with SAD prescribed paroxetine tablets during study period
Drug: Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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