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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 9, 2011
Last updated: June 6, 2013
Last verified: May 2013

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

Condition Intervention
Social Phobia
Drug: Paroxetine

Study Type: Observational
Official Title: Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed paroxetine tablets
Subjects with SAD prescribed paroxetine tablets during study period
Drug: Paroxetine


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376271

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376271     History of Changes
Other Study ID Numbers: 114102
Study First Received: June 9, 2011
Last Updated: June 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014