Benzamide Derivates as Treatment of Clozapine-Induced Hypersalivation - Full Text View

Purpose

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, Tiapride, Moclobemide	Phase III

MedlinePlus related topics:

Mental Health

Drug Information available for:

Clozapine Amisulpride Sultopride Tiapride Moclobemide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-Induced Hypersalivation: Pilot Double Phase Study: Open and Double-Blind

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 ]

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534573

Contacts


Contact: Vladimir Lerner, MD,PhD	+972 86401408	lernervld@yahoo.com

Contact: Chanoch Miodownik, MD	+972 86401404	chanoch_m@yahoo.com

Locations


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

Sponsors and Collaborators

Beersheva Mental Health Center

Investigators


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:	Dmitri Novitski, MD	Tirat HaKarmek Mental Health Center

More Information

Study ID Numbers:	LCK4569, ISRCTN4569
First Received:	September 24, 2007
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00534573
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Mouth Diseases

Sialorrhea

Dopamine

Tiapride

Moclobemide

Clozapine

Sultopride

Stomatognathic Diseases

Salivary Gland Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Dopamine Antagonists

Antipsychotic Agents

Pharmacologic Actions

Therapeutic Uses

Monoamine Oxidase Inhibitors

Dopamine Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on December 10, 2008

Sponsored by:	Beersheva Mental Health Center
Information provided by:	Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00534573