An early Phase II clinical trial of BW234U in the treatment of acute schizophrenia in newly admitted patients

Abstract

Sixteen schizophrenic patients, who were newly admitted to hospital from the emergency room, underwent a 3–6-day washout before being treated for 4 weeks with BW234U, a dimethylpiperazinyl-propylcarbazole derivative. Eight patients showed moderate to marked improvement in schizophrenic symptoms and there was a statistically significant (P<0.001) reduction in the mean score for Clinical Global Impressions in all patients. Four patients did not complete the trial; two because of poor therapeutic effect, one because of a grand-mal seizure and one because of an episode of loss of consciousness of unknown origin. BW234U showed no evidence of neuroleptic plasma activity (as measured by radioreceptor assay), did not induce plasma prolactin elevation and did not appear to cause parkinsonism.