Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

Phase 3

Completed

• Conditions: Clozapine-induced Hypersalivation
• Interventions: Drug: Amisulpride, Moclobemide

• Registration Number: NCT00534573
• Lead Sponsor: Beersheva Mental Health Center

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.

Study Timeline

• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Study Start: 2008-11
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-11
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moclobemide,	Amisulpride, Moclobemide	treatment during 2 weeks
Amisulpride	Amisulpride, Moclobemide	Comparison

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CGI, NHRS	two weeks	CGI, NHRS

Trial Locations

Locations (1)

Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center; 🇮🇱 Be'er Sheva, Haifa, Israel