Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
- Registration Number
- NCT01376128
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects prescribed PAXIL Paroxetine Pediatric subjects with panic disorder prescribed PAXIL during study period
- Primary Outcome Measures
Name Time Method Incidence of adverse events in Japanese pediatric subjects with panic disorder treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years Efficacy evaluation based on overall improvement From the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years
- Secondary Outcome Measures
Name Time Method