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Abstract
The purpose of this study was to establish whether a past psychiatric history could play a role in the development of psychiatric treatment-emergent adverse events (PTEAEs) in patients randomized to perampanel (PER) or placebo.The development of PTEAEs was compared between patients with/without a psychiatric history in a post hoc analysis from four randomized placebo-controlled trials (RPCTs) of PER (304/305/306/335) in patients with treatment-resistant focal epilepsy.Among the 2,187 patients enrolled in the RPCTs, 352 (16.1%) had a psychiatric history (PER n?=?244; placebo n?=?108), while 1835 patients (83.9%) did not (PER n?=?1325; placebo n?=?510). Compared to patients without a psychiatric history, those with a positive history reported more PTEAEs for both patients randomized to PER (11.8% vs. 29.9%, p?
View details for DOI 10.1016/j.yebeh.2021.108380
View details for PubMedID 34735963