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

Sponsor:	Beersheva Mental Health Center
Collaborator:	Tirat Carmel Mental Health Center
Information provided by:	Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00534573

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, Moclobemide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Mental Health

Drug Information available for: Sultopride Moclobemide Amisulpride Clozapine

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
NHRS, CGI

Secondary Outcome Measures:

CGI, NHRS [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
CGI, NHRS

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 Comparison	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.

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

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

Tirat Carmel 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:	Diana Shestakova, MD	Tirat HaKarmel Mental Health Center

More Information

No publications provided

Responsible Party:	Prof. Vladimir Lerner, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:	NCT00534573 History of Changes
Other Study ID Numbers:	LCK4569, ISRCTN4569, ISRCTN4569
Study First Received:	September 24, 2007
Last Updated:	June 28, 2010
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Clozapine
Sultopride
Moclobemide
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Antidepressive Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 09, 2012