
J Neuropsychiatry Clin Neurosci 19:391-398, November 2007
doi: 10.1176/appi.neuropsych.19.4.391
© 2007 American Neuropsychiatric Association
Methodological Issues in Conducting Treatment Trials for Psychological Nonepileptic Seizures
W. Curt LaFrance, Jr., M.D., M.P.H.,
Andrew S. Blum, M.D., Ph.D.,
Ivan W. Miller, Ph.D.,
Christine E. Ryan, Ph.D. and
Gabor I. Keitner, M.D.
Received July 21, 2005; revised July 7, 2006; accepted November 6, 2006. Drs. LaFrance and Blum are affiliated with the Department of Neurology and the Comprehensive Epilepsy Program, Brown Medical School, Providence, Rhode Island. Drs. LaFrance, Miller, Ryan, and Keitner are affiliated with the Department of Psychiatry and Human Behavior, Brown Medical School, Providence, Rhode Island. Address correspondence to Dr. LaFrance, Rhode Island Hospital, 593 Eddy Street, Potter 3, Neuropsychiatry, Providence, RI 02903; William_LaFrance_Jr{at}Brown.edu (e-mail).
A randomized, placebo-controlled trial has yet to be completed in patients with psychological nonepileptic seizures (NES). Treatment publications for NES are limited to class III trials and class IV reports. Little is written on the methodology of treatment trials in NES. The authors describe the procedures and limitations of such a trial to inform future NES treatment trials, based on their prospective, open-label pharmacological, feasibility trial. The authors review the recruitment, enrollment, completion of surveys, compliance, and follow-up of patients with NES. The majority of patients who enrolled, readily completed surveys and took the medication during the trial. Twelve patients were screened, eight enrolled, and six completed the trial. The authors discuss the use of outcomes and the various symptoms scales in the trial. A comprehensive neuropsychiatric initial assessment and assessing cognitive, emotional, behavioral, and psychosocial measures are important for monitoring the outcomes in NES treatment RCTs.
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