A Comparison of Instruments to Measure Depressive Symptoms among Patients with Refractory Partial-Onset Seizures (P3.192)

OBJECTIVE: To examine agreement between two instruments used to assess depressive symptoms (DS) in patients with epilepsy. BACKGROUND: Subjects with partial-onset seizures treated with once-daily eslicarbazepine acetate (ESL) 800 mg or 1200 mg as adjunctive therapy had significantly greater seizure frequency reduction versus placebo in three phase III, randomized, double-blind trials. Health-related quality of life, including presence of DS, was measured at baseline. METHODS: Subjects were administered the 10-item interview-based Montgomery Asberg Depression Rating Scale (MADRS) and self-completed the Quality of Life in Epilepsy Inventory 31 (QOLIE-31). The 5-item Emotional Well Being (EWB) QOLIE-31 subscale has been independently validated as the Mental Health Index-5 mood assessment. The MADRS, developed for clinician use in depressed patients, is scored from 0 to 60 with moderate-to-severe DS defined as 蠅20. The EWB is scored from 0 to 100 with ≤52 as a commonly-used cutoff for DS. Cohen’s kappa was calculated to measure agreement between the scores of the two instruments. McNemar’s test was used to compare proportions of subjects classified with DS and calculate the discordance odds ratio (OR). RESULTS: At baseline, 1003 of 1006 per-protocol subjects had MADRS and EWB scores. Κappa was 0.17 (95[percnt] CI: 0.11, 0.21). The EWB categorized a significantly higher percentage of subjects with DS than the MADRS (33.8[percnt] vs. 8.7[percnt]; Χ 2 =207.5, Pu003c0.0001). Additionally, among 339 subjects with DS via the EWB, the MADRS classified 279 (82.3[percnt]) as not having moderate-to-severe DS, and among 87 subjects with moderate-to-severe DS via the MADRS, the EWB classified 27 (31.0[percnt]) as non-symptomatic. CONCLUSIONS: In this pooled subgroup analysis, there was poor agreement between MADRS and EWB scores (Κappau003c0.40). While both instruments continue to be useful for measuring depressive symptoms, criteria-based clinical evaluations are needed to more fully evaluate the impact of AEDs on depression. STUDY SUPPORTED BY: Sunovion Pharmaceuticals, Inc. Disclosure: Dr. Bond has received personal compensation for activities with Covance as an employee. Dr. Velez has received personal compensation for activities with Sunovion as an employee. Dr. Anastassopoulos has received personal compensation for activities with Covance as an employee. Dr. Wang has received personal compensation for activities with Covance as an employee. Dr. Cramer has received personal compensation for activities with Bial, Eisai Inc., Sepracor, UCB Pharma, and Sunovion as a consultant. Dr. Cheng has received personal compensation for activities with Sunovian Pharmaceuticals, Inc. Dr. Sousa has received personal compensation for activities with Bial as an employee. Dr. Blum has received personal compensation for activities with Sunovion Pharmaceuticals Inc. as an employee.