A study of clozapine combined with or without pipotiazine palmitate in refractory schizophrenia

Objective: To explore the efficacy and safety of pipotiazine palmitate and clozapine combination for the treatment of chronic refractory schizophrenia (CRS). Another aim is to assess the influence of pipotiazine palmitate on serum clozapine concentration. Method: 84 CRS patients were randomly assigned to two groups (clozapine with pipotiazine or clozapine alone) for 6 months. Serum clozapine concentrations were measured with HPLC,efficacy and side effects were assessed with the brief psychiatric rating scale (BPRS),treatment emergent symptom scale (TESS) before and after the treatment (1,2,3,6 month). Results:Clozapine combined with pipotiazine was superior to clozapine alone. Total BPRS and factors scores (except anxious-depression factor) decreased significantly more in clozapine-pipotiazine group than in clozapine group, but there was no significant difference in TESS. Blood clozapine concentration in patients with significant improvement were all higher than 350μg/L. Conclusion:Clozapine-pipotiazine is a highly effective and safe treatment for chronic refractory schizophrenia. Pipotiazine has little influence on serum clozapine concentration.