Downloadable from the GSK website
Study Medication: Paroxetine
Cause of Death: Suicide (by hanging)
This 58 year old female had hypertension on entry to the study. She had been receiving metoprolol 100mg daily and amiloride plus hydrochlorothiazide from day 54.
She had suffered five or six previous episodes of depression for which she had received treatment with bi/tri/tetracyclic antidepressants and benzodiazepines. The duration of the present episode of depression was recorded as 1 to 3 months. She had received previous treatment for this episode with bi/tri/tetracyclic antidepressants, which were stopped on day 1, and benzodiazepines, which were stopped on day 4.
The patient received 20mg paroxetine from days 0 to 8. She also received temazepam 20mg, twice or three times daily, from day 0, and chloral hydrate 500mg daily from day 1.
The patient experienced a moderately decreased appetite and mild dryness of the mouth from day 2; both events were considered to be probably related to study treatment.
The patient did not have any double flagged changes in vital signs data and only baseline laboratory assessments were performed. On day 8 the patient committed suicide by hanging (preferred term: emotional lability).
The investigator considered this to be unrelated to study treatment.
CONFIDENTIAL Seroxat Article 31 - Consolidated Response Document - January 04
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