Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Panic Disorder

Treatments: Drug: Paroxetine

Study type: Observational

Funder types: Industry

Identifiers

NCT01376128

112309

Details and patient eligibility

About

The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets ("PAXIL", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.

Enrollment: 96 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged under 18 at the time of the panic disorder diagnosis
• Aged under 18 on the starting day of PAXIL treatment
• Having been making periodic visits to the hospital to receive treatment for panic disorder

Exclusion criteria

• Subjects who have been treated with paroxetine prior to this investigation
• Subjects with hypersensitivity to paroxetine
• Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
• Concomitant use in patients taking pimozide

Trial design

96 participants in 1 patient group

Subjects prescribed PAXIL

Description:

Pediatric subjects with panic disorder prescribed PAXIL during study period

Treatment:

Drug: Paroxetine