The initial US clinical experience in the management of schizophrenic patients with bromperidol.

Observations and conclusions from initial acute and maintenance bromperidol clinical trials conducted in the USA are presented along with an overview of the clinical development program. Thirty diagnosed schizophrenic patients, recruited from private practice, were admitted to either study. Patients were controlled with bromperidol administered only once daily. The acute patients received an average dose of 14-23 mg day during the month-long inpatient stay. The average maintenance dose was calculated to be approximately 8 mg. Overall, patients received from 3-39 mg for up to four months. Pre-treatment vs. 4 week treatment BPRS scores showed highly significant decreases in the five NCDEU (New Clinical Drug Evaluation Unit, which developed the accepted US psychiatric rating scales) behavioral symptom clusters analyzed. Two thirds of the patients were much to very much improved over this same interval based on clinical global ratings. Minimal side effects were noted. In particular, fewer acute neuromuscular reactions and less weight gain were noted. Based on the experience to date, bromperidol will be a significant addition to the therapeutic armamentarium for the management of schizophrenia in both acute and chronic cases.