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Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

NCT00534573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-07-26

No results posted yet for this study

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.

Conditions

  • Clozapine-induced Hypersalivation

Interventions

DRUG

Amisulpride, Moclobemide

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

Sponsors & Collaborators

  • Tirat Carmel Mental Health Center

    collaborator OTHER_GOV

  • Beersheva Mental Health Center

    lead OTHER_GOV

Principal Investigators

  • Vladimir Lerner, MD, PhD · Be'er Sheva Mental Health Center

  • Anatoly Kreinin, MD, PhD · Tirat HaKarmel Mental Health Center

  • Chanoch Miodownik, MD · Be'er Sheva Mental Health Center

  • Igor Libov · Be'er Sheva Mental Health Center

  • Alexander Grinshpoon, MD · Tirat HaKarmel Mental Health Center

  • Diana Shestakova, MD · Tirat HaKarmel Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534573 on ClinicalTrials.gov