Methodological issues in conducting treatment trials for psychological nonepileptic seizures

J Neuropsychiatry Clin Neurosci. Fall 2007;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.

Abstract

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.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Anticonvulsants / therapeutic use
  • Anxiety / complications
  • Anxiety / psychology
  • Clinical Trials as Topic*
  • Depression / complications
  • Depression / psychology
  • Feasibility Studies
  • Female
  • Humans
  • Impulsive Behavior / complications
  • Impulsive Behavior / psychology
  • Male
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Risk Factors
  • Seizures / complications
  • Seizures / drug therapy*
  • Seizures / psychology*
  • Social Behavior
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Anticonvulsants