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| Sponsor: | Beersheva Mental Health Center |
|---|---|
| Collaborator: |
Tirat Carmel Mental Health Center |
| Information provided by: | Beersheva Mental Health Center |
| ClinicalTrials.gov Identifier: | NCT00534573 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Clozapine-induced Hypersalivation |
Drug: Amisulpride, Tiapride, Moclobemide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind |
| Enrollment: | 45 |
| Study Start Date: | November 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center | |
| Be'er Sheva, Haifa, Israel | |
| 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 |
More Information
| Responsible Party: | Beersheva Mental Health Center ( Prof. Vladimir Lerner ) |
| Study ID Numbers: | LCK4569, ISRCTN4569 |
| Study First Received: | September 24, 2007 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00534573 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Mouth Diseases Neurotransmitter Agents Sialorrhea Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Tiapride Sultopride Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Therapeutic Uses Moclobemide Monoamine Oxidase Inhibitors Dopamine Agents Stomatognathic Diseases Salivary Gland Diseases Central Nervous System Agents Antidepressive Agents |
