An observational study in Mental Disorders, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by GlaxoSmithKline · Observational
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 3,708 is above the median of 200 across 480 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Japanese subjects with depression/depressed state or panic disorder who were indicated for PAXIL
Exclusion Criteria:
Patients with depression/depressed state or panic disorder prescribed PAXIL during study period
Drug: Paroxetine
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
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.
Time frame: 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.
Time frame: 8 weeks
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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