Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534573

Acronym

CIH

Enrollment

Registered

2007-09-26

Start date

2008-11-30

Completion date

2009-01-31

Last updated

2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clozapine-induced Hypersalivation

Brief 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.

Detailed description

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.

Interventions

DRUGAmisulpride, Moclobemide

Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hypersalivation will be assessed by subjective and objective tools. Clinical global impression (CGI) patient's self assessment will be taken as subjective tool and NHRS as an objective assessment tool.	every two days	NHRS, CGI

Secondary

Measure	Time frame	Description
CGI, NHRS	two weeks	CGI, NHRS

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026