CIH: Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation

• Sponsor: Beersheva Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00534573
• Collaborator: Tirat Carmel Mental Health Center (Other)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 26.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clozapine-induced Hypersalivation	Drug: Amisulpride, Moclobemide	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Moclobemide, treatment during 2 weeks	Drug: Amisulpride, Moclobemide; Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
Active Comparator: Amisulpride Comparison	Drug: Amisulpride, Moclobemide; Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout

Outcome Measures

Primary Outcome Measures

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. [every two days]

   NHRS, CGI

Secondary Outcome Measures

1. CGI, NHRS [two weeks]

   CGI, NHRS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center	Be'er Sheva, Haifa		Israel

Sponsors and Collaborators

• Beersheva Mental Health Center
• Tirat Carmel Mental Health Center

Investigators

• Principal Investigator: Vladimir Lerner, MD, PhD, Be'er Sheva Mental Health Center
• Principal Investigator: Anatoly Kreinin, MD, PhD, Tirat HaKarmel Mental Health Center
• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vladimir Lerner, A/Professor, Head of department, Beersheva Mental Health Center
• ClinicalTrials.gov Identifier: NCT00534573
• Other Study ID Numbers: LCK4569; ISRCTN4569; ISRCTN4569
• First Posted: Sep 26, 2007
• Last Update Posted: Jul 26, 2012
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Sialorrhea; Amisulpride; Moclobemide

Study Results

No Results Posted as of Jul 26, 2012