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

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01371448
• Other study ID #: 112302
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 7, 2017
• Start date: May 2001
• Est. completion date: September 2005

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: September 2005
• Est. primary completion date: September 2004
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Paroxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice		1 year
Primary	Presence/absence of concomitant use of drugs metabolized by CYP2D6	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.	Within 2 weeks after discontinuation or completion of treatment
Primary	Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)	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.	1 year