Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Drug Use Investigation for PAXIL Tablet

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 9, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

This post-marketing 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.

Condition Intervention
Mental Disorders
Drug: Paroxetine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for PAXIL Tablet

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Presence/absence of concomitant use of drugs metabolized by CYP2D6 [ Time Frame: Within 2 weeks after discontinuation or completion of treatment ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 3708
Study Start Date: April 2001
Study Completion Date: December 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed PAXIL
Patients with depression/depressed state or panic disorder prescribed PAXIL during study period
Drug: Paroxetine


Genders Eligible for Study:   Both
Sampling Method:   Probability Sample
Study Population

Japanese subjects with depression/depressed state or panic disorder who were indicated for PAXIL


Inclusion Criteria:

  • Patients with depression/depressed state or panic disorder

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01371435

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT01371435     History of Changes
Other Study ID Numbers: 112301
Study First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency processed this record on February 27, 2015