Methodological issues in conducting treatment trials for psychological nonepileptic seizures.
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.
LaFrance
W Curt
WC
Department of Neurology, Comprehensive Epilipsy Program, Brown Medical School, Providence, Rhode Island, USA. William_LaFrance_Jr@Brown.edu
Blum
Andrew S
AS
Miller
Ivan W
IW
Ryan
Christine E
CE
Keitner
Gabor I
GI
D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use; D001007:Anxiety / Q000150:complications / Q000523:psychology; D002986:Clinical Trials as Topic; D003863:Depression / Q000150:complications / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007175:Impulsive Behavior / Q000150:complications / Q000523:psychology; D008297:Male; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012307:Risk Factors; D012640:Seizures / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D012919:Social Behavior; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000927:Anticonvulsants