A clinical and pharmacodynamic evaluation of sulpiride.

In a double-blind study the therapeutic efficacy of sulpiride was compared to that of haloperidol--an established neuroleptic agent. A total of 30 female patients with a diagnosis of chronic schizophrenia were initially stabilised on the dosage of haloperidol which produced optimum therapeutic response when given once or twice daily. The patients were then randomly allocated to receive either sulpiride or haloperidol over a period of 12 weeks. Plasma drug concentrations and prolactin levels were determined. Clinical effects were evaluated by Brief Psychiatric Rating Scale (BPRS), Wing Rating Scale, and Extrapyramidal Symptoms Rating Scale (EPS). A standardised side-effects checklist was used. Treatment with sulpiride was associated with a significant rise in plasma prolactin level, but paradoxically these patients had significantly reduced extrapyramidal symptoms. No significant correlation was found between plasma sulpiride concentration and prolactin level or any of the clinical variables. The study confirms the antipsychotic activity of sulpiride.