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Abstract Details

Psychiatric Adverse Events According to Psychiatric History and Current Status: A Post-hoc Analysis of Three Phase III Trials of Adjunctive Eslicarbazepine Acetate in Adults with Focal Seizures
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (12:00 PM-1:00 PM)
12-006

To evaluate the occurrence of psychiatric adverse events (AEs) in clinical trials of adjunctive eslicarbazepine acetate (ESL) in adults with focal seizures, according to psychiatric history and current symptom status.

ESL is a once-daily (QD), oral antiepileptic drug (AED) for focal (partial-onset) seizures.

Data were pooled from three Phase III, randomized, double-blind, placebo-controlled trials (BIA-2093-301, -302, -304). After an 8-week baseline period, adults with ≥4 focal seizures/month taking 1–3 AEDs were randomized equally to receive placebo, ESL 400 mg (not reported here), 800 mg, or 1200 mg QD (2-week titration; 12-week maintenance). Incidences of psychiatric treatment-emergent AEs (TEAEs) were evaluated according to: medical history of psychiatric disorders (yes/no); Montgomery-Åsberg Depression Rating Scale (MADRS) score at baseline (0–6: normal; 7–19: mild depression; 20–34: moderate depression); use of concomitant psychotropic drugs (yes/no).
The safety population comprised 1447 patients. The frequency of psychiatric TEAEs was higher in patients with a medical history of psychiatric disorders than in those with no such history (placebo, 17.3% vs 5.2%; ESL 800 mg, 9.8% vs 7.1%; ESL 1200 mg, 12.8% vs 5.4%), as were the frequencies of anxiety and depression. The frequency of psychiatric TEAEs was higher in patients using concomitant psychotropic drugs than in those not (placebo, 18.8% vs 6.6%; ESL 800 mg, 15.1% vs 6.6%; ESL 1200 mg, 21.1% vs 5.6%), as was the frequency of depression. The frequency of psychiatric TEAEs was greater in patients with mild or moderate depression at baseline (according to MADRS), than in those categorized as ‘normal’, across treatment groups. 
In clinical trials of ESL in adults with focal seizures, psychiatric TEAEs generally occurred more frequently in patients with current psychiatric symptoms or a history of psychiatric disorders, with no marked differences between the placebo and ESL treatment groups. 
Authors/Disclosures
Hamada H. Altalib, DO (VA Connecticut Healthcare System)
PRESENTER 		The institution of Dr. Altalib has received research support from UCB. The institution of Dr. Altalib has received research support from DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS.
Todd Grinnell, PhD Todd Grinnell, PhD has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
David Cantu, PhD (Xenon Pharmaceuticals Inc) Dr. Cantu has received personal compensation for serving as an employee of Sunovion Pharmaceuticals Inc..
Fabio Ikedo Fabio Ikedo has received personal compensation for serving as an employee of Bial.
No disclosure on file
No disclosure on file
No disclosure on file