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OpenTrials
Completed

NCT Number: NCT01376128

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

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

Primary outcomes

  1. 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

    Time frame: 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

  2. Efficacy evaluation based on overall improvement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2011
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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