Seizure incidence in psychopharmacological clinical trials: an analysis of Food and Drug Administration (FDA) summary basis of approval reports.

@article{Alper2007SeizureII,
  title={Seizure incidence in psychopharmacological clinical trials: an analysis of Food and Drug Administration (FDA) summary basis of approval reports.},
  author={Kenneth Robert Alper and Kelly A Schwartz and Russell L Kolts and Arif Khan},
  journal={Biological psychiatry},
  year={2007},
  volume={62 4},
  pages={345-54}
}
BACKGROUND Clinical trial data provide an approach to the investigation of the effects of psychopharmacological agents, and psychiatric disorders themselves, on seizure threshold. METHODS We accessed public domain data from Food and Drug Administration (FDA) Phase II and III clinical trials as Summary Basis of Approval (SBA) reports that noted seizure incidence in trials of psychotropic drugs approved in the United States between 1985 and 2004, involving a total of 75,873 patients. We… CONTINUE READING
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