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Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

NCT ID: NCT00534573

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Clozapine-induced Hypersalivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Moclobemide,

treatment during 2 weeks

Group Type ACTIVE_COMPARATOR

Amisulpride, Moclobemide

Intervention Type DRUG

Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Amisulpride

Comparison

Group Type ACTIVE_COMPARATOR

Amisulpride, Moclobemide

Intervention Type DRUG

Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Interventions

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Amisulpride, Moclobemide

Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tirat Carmel Mental Health Center

OTHER_GOV

Sponsor Role collaborator

Beersheva Mental Health Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Vladimir Lerner

A/Professor, Head of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Lerner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Be'er Sheva Mental Health Center

Anatoly Kreinin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tirat HaKarmel Mental Health Center

Chanoch Miodownik, MD

Role: STUDY_DIRECTOR

Be'er Sheva Mental Health Center

Igor Libov

Role: STUDY_DIRECTOR

Be'er Sheva Mental Health Center

Alexander Grinshpoon, MD

Role: STUDY_DIRECTOR

Tirat HaKarmel Mental Health Center

Diana Shestakova, MD

Role: STUDY_DIRECTOR

Tirat HaKarmel Mental Health Center

Locations

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

Be'er Sheva, Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 20964499 (View on PubMed)

Other Identifiers

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ISRCTN4569

Identifier Type: -

Identifier Source: secondary_id

ISRCTN4569

Identifier Type: OTHER

Identifier Source: secondary_id

LCK4569

Identifier Type: -

Identifier Source: org_study_id