Drug Use Investigation for PAXIL Tablet
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|ClinicalTrials.gov Identifier: NCT01371435|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment|
|Mental Disorders||Drug: Paroxetine|
|Study Type :||Observational|
|Actual Enrollment :||3708 participants|
|Official Title:||Drug Use Investigation for PAXIL Tablet|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||December 2005|
Patients prescribed PAXIL
Patients with depression/depressed state or panic disorder prescribed PAXIL during study period
- 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 ]
- Presence/absence of concomitant use of drugs metabolized by CYP2D6 [ Time Frame: 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) [ Time Frame: 8 weeks ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371435
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|