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

Beersheva Mental Health Center

Status and phase: Completed; Phase 3

Conditions: Clozapine-induced Hypersalivation

Treatments: Drug: Amisulpride, Moclobemide

Study type: Interventional

Funder types: Other

Identifiers

NCT00534573

ISRCTN4569

LCK4569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Moclobemide,

Active Comparator group

Description:

treatment during 2 weeks

Treatment:

Drug: Amisulpride, Moclobemide

Amisulpride

Active Comparator group

Description:

Comparison

Treatment:

Drug: Amisulpride, Moclobemide