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Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation (CIH)

This study has been completed.
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center Identifier:
First received: September 24, 2007
Last updated: July 25, 2012
Last verified: November 2009

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.

Condition Intervention Phase
Clozapine-induced Hypersalivation
Drug: Amisulpride, Moclobemide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind

Resource links provided by NLM:

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • 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. [ Time Frame: every two days ]

Secondary Outcome Measures:
  • CGI, NHRS [ Time Frame: two weeks ]

Enrollment: 54
Study Start Date: November 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moclobemide,
treatment during 2 weeks
Drug: Amisulpride, Moclobemide
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
Active Comparator: Amisulpride
Drug: Amisulpride, Moclobemide
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00534573

Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center
Be'er Sheva, Haifa, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Tirat Carmel Mental Health Center
Principal Investigator: Vladimir Lerner, MD, PhD Be'er Sheva Mental Health Center
Principal Investigator: Anatoly Kreinin, MD, PhD Tirat HaKarmel Mental Health Center
Study Director: Chanoch Miodownik, MD Be'er Sheva Mental Health Center
Study Director: Igor Libov Be'er Sheva Mental Health Center
Study Director: Alexander Grinshpoon, MD Tirat HaKarmel Mental Health Center
Study Director: Diana Shestakova, MD Tirat HaKarmel Mental Health Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vladimir Lerner, A/Professor, Head of department, Beersheva Mental Health Center Identifier: NCT00534573     History of Changes
Other Study ID Numbers: LCK4569
ISRCTN4569 ( Other Identifier: ISRCTN4569 )
Study First Received: September 24, 2007
Last Updated: July 25, 2012

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors processed this record on May 23, 2017