Special Drug Use Investigation for PAXIL Tablet (Long-term)
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).
|Study Design:||Time Perspective: Prospective|
|Official Title:||Special Drug Use Investigation for PAXIL Tablet (Long-term)|
- Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice [ Time Frame: 1 year ] [ 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: 1 year ] [ 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.
|Study Start Date:||May 2001|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
Patients prescribed PAXIL for long-term use
Patients with depression/depressed state or panic disorder prescribed PAXIL during study period
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371448
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|