Abstract
hagen), and is being developed as an antipsychotic in the United States by the Psychopharmacology Venture of Ablxnt Laboratories. Sertindole is a potent antagonist with nanomolar affinities for dopamine D2, serotonin 5-HT2, and norepinephrine alpha-1 receptors. In vivo electrophysiological animal studies of sertindole have shown a 100-fold greater selectivity for ventral tegrnental area dopaminergic neurons over substantia nigra pars compacta neurons; thus, it is hypothesized that sertindole will be an effective antipsychotic agent with minimal neurological side effects. Sertindole study M93-098 is a phase 111, double-blind, placebo-controlled, fixed-dose, Haldol© (halopoeridol)-referenced (16 mg daily), randomized, 8-week trial of two doses of sertindole (20 and 24 mg daily) in schizophrenic patients. Twenty-nine centers in the United States will enroll approximately 400 patients. Efficacy will be assessed primarily by the PANSS total score. Effects on motor function will be assessed, as compared to Haldol, by the appearance of motor system adverse effects, the use of benztropine mesylate and several specific rating scales (SAS, BAS, and ALMS). Safety will be assessed by adverse event monitoring, clinical laboratory analysis, and electrocardiograms. The results of this study will be presented.
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