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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376271
First received: June 9, 2011
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

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: October 2012
Estimated Primary Completion Date: July 2012 (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

  Eligibility

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

Criteria

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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01376271     History of Changes
Other Study ID Numbers: 114102
Study First Received: June 9, 2011
Last Updated: June 23, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Paroxetine
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 May 16, 2013