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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01376128
Enrollment
96
Registered
2011-06-20
Start date
2008-03-31
Completion date
2009-05-31
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic Disorder

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.

Interventions

DRUGParoxetine

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years

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

Design outcomes

Primary

MeasureTime frame
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 practiceFrom 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 improvementFrom the starting day of the treatment to the time of treatment termination/discontinuation was assessed from 1 month at minimum up to 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026