NCT01376271

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

3.7 years

First QC Date

June 9, 2011

Last Update Submit

June 30, 2014

Conditions

Social Phobia

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (1)

Subjects prescribed paroxetine tablets

Subjects with SAD prescribed paroxetine tablets during study period

Drug: Paroxetine

Interventions

ParoxetineDRUG
Subjects prescribed paroxetine tablets

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phobia, Social

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 20, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-06