Special Drug Use Investigation for PAXIL Tablet (Long-term)

Completed

• Conditions: Mental Disorders
• Interventions: Drug: Paroxetine

• Registration Number: NCT01371448
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine in long-term use (1 year).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Primary Completion: 2004-09
• Study Completion: 2005-09
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

• Patients with depression/depressed state or panic disorder
• PAXIL must be used for long-term

Exclusion Criteria

• Patients who had been taking PAXIL since before the start of the survey
• Patients with hypersensitivity to paroxetine
• Patients 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
Patients prescribed PAXIL for long-term use	Paroxetine	Patients with depression/depressed state or panic disorder prescribed PAXIL during study period

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice	1 year
Presence/absence of concomitant use of drugs metabolized by CYP2D6	Within 2 weeks after discontinuation or completion of treatment	PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof.
Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)	1 year	Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use.