Objective: There have been few treatment trials for psychogenic nonepileptic seizures (PNES).Some psychotherapies have been shown to improve PNES and comorbid symptom outcomes. We evaluated a pharmacologic intervention to test the hypothesis that sertraline would reduce PNES.
Methods:We conducted a pilot, double-blind, randomized, placebo-controlled trial in an academic medical hospital with epilepsy center outpatients. Subjects aged 18 to 65 years diagnosed with video-EEG-confirmed PNES were treated with flexible-dose sertraline or placebo over 12 weeks. Seizure calendars and symptom scales were charted prospectively. Secondary outcome measures included psychiatric symptom scales and psychosocial variables.Results: Thirty-eight subjects enrolled, and 26 (68%) completed the trial. Thirty-three subjects with nonzero nonepileptic seizure rates at baseline were included in intent-to-treat analysis of the primary outcome. Subjects assigned to the sertraline arm experienced a 45% reduction in seizure rates from baseline to final visit (p ϭ 0.03) vs an 8% increase in placebo (p ϭ 0.78). Secondary outcome scales revealed no significant between-group differences in change scores from baseline to final visit, after adjustment for differences at baseline.Conclusions: PNES were reduced in patients treated with a serotonin selective reuptake inhibitor, whereas those treated with placebo slightly increased. This study provides feasibility data for a larger-scale study.
Level of evidence:This study provides Class II evidence that flexible-dose sertraline up to a maximum dose of 200 mg is associated with a nonsignificant reduction in PNES rate compared with a placebo control arm (risk ratio 0.51, 95% confidence interval 0.25-1.05, p ϭ 0.29), adjusting for differences at baseline. Neurology ® 2010;75:1166-1173 GLOSSARY AED ϭ antiepileptic drug; CI ϭ confidence interval; DSM-IV ϭ Diagnostic and Statistical Manual of Mental Disorders, 4th edition; ES ϭ epileptic seizures; ITT ϭ intent to treat; PNES ϭ psychogenic nonepileptic seizures; PTSD ϭ posttraumatic stress disorder; QOL ϭ quality of life; RCT ϭ randomized controlled trial; RIH ϭ Rhode Island Hospital; RR ϭ risk ratio; SSRI ϭ serotonin selective reuptake inhibitor; vEEG ϭ video-EEG.