Clozapine-induced Hypersalivation Clinical Trial
Official title:
Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind
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.
The pilot study will be conducted in two mental health centers. In order to examine our hypothesis, we will use an add-on design. Into the study will be enrolled 50 patients with schizophrenia and schizoaffective disorder (males and females, 19-60 years old), according to the DSM-IV criteria, treated with clozapine and suffering from hypersalivation. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02222220 -
Metoclopramide as Treatment of Clozapine-induced Hypersalivation
|
Phase 3 |