Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
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ClinicalTrials.gov Identifier: NCT01376128 |
Recruitment Status :
Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
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Condition or disease | Intervention/treatment |
---|---|
Panic Disorder | Drug: Paroxetine |
Study Type : | Observational |
Actual Enrollment : | 96 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder) |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | May 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Subjects prescribed PAXIL
Pediatric subjects with panic disorder prescribed PAXIL during study period
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Drug: Paroxetine |
- 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 ]
- 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 ]

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Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376128
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01376128 |
Other Study ID Numbers: |
112309 |
First Posted: | June 20, 2011 Key Record Dates |
Last Update Posted: | May 22, 2017 |
Last Verified: | May 2017 |
Panic Disorder Anxiety Disorders Mental Disorders Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |