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

NCT01371448 | Completed

• 1 other identifier: 112302
• Study Type: observational
• Target: 339
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (3)

• 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

  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

• 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

Study Arms (1)

Patients prescribed PAXIL for long-term use

Patients with depression/depressed state or panic disorder prescribed PAXIL during study period

Drug: Paroxetine

Interventions

Paroxetine DRUG

Patients prescribed PAXIL for long-term use

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with depression/depressed state or panic disorder which are the indications of PAXIL for long-term use

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Mental Disorders

Interventions

Paroxetine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 10, 2011
• Study Start: May 1, 2001
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: June 8, 2017

Record last verified: 2017-05