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

July 25, 2012 updated by: Vladimir Lerner, Beersheva Mental Health Center

Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Comparison
Drug: Amisulpride, Moclobemide
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
NHRS, CGI
every two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI, NHRS
Time Frame: two weeks
CGI, NHRS
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beersheva Mental Health Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 24, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCK4569
  • ISRCTN4569 (Other Identifier: ISRCTN4569)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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