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Completed

NCT Number: NCT00534573

Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

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.

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Key information

Conditions

Clozapine-induced Hypersalivation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Be'er Sheva, Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amisulpride, Moclobemide

Drug

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

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.

    Time frame: every two days

    NHRS, CGI

Secondary outcomes

  1. CGI, NHRS

    Time frame: two weeks

    CGI, NHRS

Sponsors and collaborators

Lead sponsor

Beersheva Mental Health Center

Other Gov

Collaborators

  • Tirat Carmel Mental Health Center

Registry information

Official study title

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

Acronym: CIH

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2007
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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