Metoclopramide as Treatment of Clozapine-induced Hypersalivation

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no effective enough treatment for this side effect.

Previous studies demonstrated that different medications from the substitute benzamide derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in general medicine). The investigators hypothesis assumes that anti-salivation effect characterizes the whole group of benzamide.

The aim of this study was to examine the efficacy of metoclopramide as an optional possibility for management of CIH.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beersheva Mental Health Center
• Collaborator: Tirat Carmel Mental Health Center
• Treatments: Clozapine; Metoclopramide

Criteria

Inclusion Criteria:

• Age 18-60 years, male or female

• DSM-IV criteria for schizophrenia

• Clozapine treatment

• At least score >2 on the Nocturnal Hypersalivation Rating Scale (NHRS)

Exclusion Criteria:

• Evidence of organic brain damage, mental retardation, alcohol or drug abuse

• Patients suffering from pheochromocytoma

• Patients suffering from Parkinson's disease