Clinical trial NCT00534573: Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clozapine-induced Hypersalivation
Lead sponsor: Beersheva Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Tirat Carmel Mental Health Center
First posted: 2007-09-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: every two days
Secondary outcomes:
measure: CGI, NHRS
timeFrame: two weeks
Other outcomes:
Locations:
city: Be'er Sheva, Haifa
country: Israel
facility: Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center
Study officials:
affiliation: Be'er Sheva Mental Health Center
name: Vladimir Lerner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tirat HaKarmel Mental Health Center
name: Anatoly Kreinin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Be'er Sheva Mental Health Center
name: Chanoch Miodownik, MD
role: STUDY_DIRECTOR
affiliation: Be'er Sheva Mental Health Center
name: Igor Libov
role: STUDY_DIRECTOR
affiliation: Tirat HaKarmel Mental Health Center
name: Alexander Grinshpoon, MD
role: STUDY_DIRECTOR
affiliation: Tirat HaKarmel Mental Health Center
name: Diana Shestakova, MD
role: STUDY_DIRECTOR
References:
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.