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

Primary Purpose

Clozapine-induced Hypersalivation

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Amisulpride, Moclobemide
Sponsored by
Beersheva Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clozapine-induced Hypersalivation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moclobemide,

Amisulpride

Arm Description

treatment during 2 weeks

Comparison

Outcomes

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.
NHRS, CGI

Secondary Outcome Measures

CGI, NHRS
CGI, NHRS

Full Information

First Posted
September 24, 2007
Last Updated
July 25, 2012
Sponsor
Beersheva Mental Health Center
Collaborators
Tirat Carmel Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT00534573
Brief Title
Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation
Acronym
CIH
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beersheva Mental Health Center
Collaborators
Tirat Carmel Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clozapine-induced Hypersalivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moclobemide,
Arm Type
Active Comparator
Arm Description
treatment during 2 weeks
Arm Title
Amisulpride
Arm Type
Active Comparator
Arm Description
Comparison
Intervention Type
Drug
Intervention Name(s)
Amisulpride, Moclobemide
Intervention Description
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
Primary Outcome Measure Information:
Title
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.
Description
NHRS, CGI
Time Frame
every two days
Secondary Outcome Measure Information:
Title
CGI, NHRS
Description
CGI, NHRS
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Lerner, MD, PhD
Organizational Affiliation
Be'er Sheva Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anatoly Kreinin, MD, PhD
Organizational Affiliation
Tirat HaKarmel Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chanoch Miodownik, MD
Organizational Affiliation
Be'er Sheva Mental Health Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Igor Libov
Organizational Affiliation
Be'er Sheva Mental Health Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexander Grinshpoon, MD
Organizational Affiliation
Tirat HaKarmel Mental Health Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Diana Shestakova, MD
Organizational Affiliation
Tirat HaKarmel Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center
City
Be'er Sheva, Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
20964499
Citation
Kreinin A, Miodownik C, Sokolik S, Shestakova D, Libov I, Bergman J, Lerner V. Amisulpride versus moclobemide in treatment of clozapine-induced hypersalivation. World J Biol Psychiatry. 2011 Dec;12(8):620-6. doi: 10.3109/15622975.2010.527370. Epub 2010 Oct 21.
Results Reference
derived

Learn more about this trial

Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

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