NCT00534573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 26, 2012

Status Verified

November 1, 2009

Enrollment Period

2 months

First QC Date

September 24, 2007

Last Update Submit

July 25, 2012

Conditions

Clozapine-induced Hypersalivation

Outcome Measures

Primary Outcomes (1)

  • 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

    every two days

Secondary Outcomes (1)

  • CGI, NHRS

    two weeks

Study Arms (2)

Moclobemide,

ACTIVE COMPARATOR

treatment during 2 weeks

Drug: Amisulpride, Moclobemide

Amisulpride

ACTIVE COMPARATOR

Comparison

Drug: Amisulpride, Moclobemide

Interventions

Amisulpride, MoclobemideDRUG

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

AmisulprideMoclobemide,

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Evidence of organic brain damage, mental retardation, alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Be'er Sheva, Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20964499DERIVED

MeSH Terms

Interventions

AmisulprideMoclobemide

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChlorobenzoates

Study Officials

  • Vladimir Lerner, MD, PhD

    Be'er Sheva Mental Health Center

    PRINCIPAL INVESTIGATOR

  • Anatoly Kreinin, MD, PhD

    Tirat HaKarmel Mental Health Center

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Professor, Head of department

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 26, 2012

Record last verified: 2009-11

Locations

IL(1)