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

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ClinicalTrials.gov Identifier: NCT00534573
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : July 26, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Clozapine-induced Hypersalivation Drug: Amisulpride, Moclobemide Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. CGI, NHRS [ Time Frame: two weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vladimir Lerner, A/Professor, Head of department, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00534573     History of Changes
Other Study ID Numbers: LCK4569
ISRCTN4569 ( Other Identifier: ISRCTN4569 )
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: November 2009

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