title: Amisulpride treatment of clozapine-induced hypersalivation in schizophrenia patients: a randomized, double-blind, placebo-controlled cross-over study.
abstract: The beneficial effect of sulpiride augmentation of clozapine therapy for treatment-resistant schizophrenia patients is enhanced by its antisalivatory effect on clozapine-induced hypersalivation (CIH). Amisulpride, similar to sulpiride, is a substitute benzamide derivative with higher selective binding to the D2/D3 dopamine receptor. We hypothesized that add-on amisulpride would also be beneficial in controlling CIH. In a randomized, double-blind, placebo-controlled cross-over study, 20 clozapine-treated schizophrenia (DSM-IV criteria) inpatients with CIH were randomly initially assigned to add-on amisulpride (nine patients; 400 mg/day up-titrated from 100 mg/day over 1 week) or placebo (11 patients). Primary outcome was change in the five-point Nocturnal Hypersalivation Rating Scale (NHRS). Other measures included the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression scale (CGI) and Simpson-Angus Scale (SAS). Mean NHRS indices were considerably lower with amisulpride (1.79 +/- 1.25) than with placebo (2.63 +/- 1.33) [F(1,38) = 5.36, P < 0.05]. With amisulpride treatment, there was a significant improvement on the negative symptoms subscale of the PANSS [F(3,57) = 3.76, P < 0.05], but not on the SAS, CGI or other subscales of the PANSS (all F < 1). Short-term amisulpride augmentation has a strong ameliorating effect on CIH. A long-term, large-scale study with a broader dose range is warranted to evaluate the stability of this effect across time.
authors.affiliation: Tirat HaCarmel Mental Health Center, Tirat HaCarmel, Felsenstein Medical Research Center, Geha Psychiatric Hospital, Petah Tiqva and Sackler Faculty of Medicine, Tel-Aviv University, Israel. tyrkreinin@matat.health.gov.il
authors.forename: Anatoly
authors.initials: A
authors.lastname: Kreinin
authors.forename: Dmitri
authors.initials: D
authors.lastname: Novitski
authors.forename: Abraham
authors.initials: A
authors.lastname: Weizman
mesh_terms: D000077582:Amisulpride; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D003024:Clozapine / Q000009:adverse effects* / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D012559:Schizophrenia / Q000188:drug therapy*; D012798:Sialorrhea / Q000139:chemically induced* / Q000188:drug therapy*; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D014150:Antipsychotic Agents; D010919:Placebos; D013469:Sulpiride; D000077582:Amisulpride; D003024:Clozapine