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

This study has been completed.
Sponsor:
Collaborator:
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00534573
First received: September 24, 2007
Last updated: July 25, 2012
Last verified: November 2009
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Beersheva Mental Health Center

Additional 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, ISRCTN4569
Study First Received: September 24, 2007
Last Updated: July 25, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Sialorrhea
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Moclobemide
Sultopride
Antidepressive Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014