Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

Clozapine-induced Hypersalivation Clinical Trial

— CIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534573
• Other study ID #: LCK4569
• Secondary ID: ISRCTN4569ISRCTN
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2007
• Last updated: July 25, 2012
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: November 2009
• Source: Beersheva Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clozapine-induced Hypersalivation
• Sialorrhea

Intervention

Drug:
• Amisulpride, Moclobemide
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Locations

Country	Name	City	State
Israel	Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center	Be'er Sheva, Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Beersheva Mental Health Center	Tirat Carmel Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	CGI, NHRS	CGI, NHRS	two weeks	Yes