Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy, and until now there is not enough effective treatment for this side effect leading to noncompliance.

In previous studies it was found that substitute benzamide derivatives with higher selective binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in Israel, there are four medications which belong to substitute benzamide derivatives group: amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect is universal for the whole group of benzamide.

The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an additional 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: Amisulpride; Clozapine; Moclobemide; Sulpiride; Sultopride

Criteria

Inclusion Criteria:

• Age 18-60 years, male or female

• DSM-IV criteria for schizophrenia

• Clozapine treatment

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

Exclusion Criteria:

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