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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN4569 | |||
| ISRCTN4569 | Other Identifier | ISRCTN4569 |
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| Name | Class |
|---|---|
| Tirat Carmel Mental Health Center | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moclobemide, | Active Comparator | treatment during 2 weeks |
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| Amisulpride | Active Comparator | Comparison |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride, Moclobemide | Drug | Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CGI, NHRS | CGI, NHRS | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Lerner, MD, PhD | Be'er Sheva Mental Health Center | Principal Investigator |
| Anatoly Kreinin, MD, PhD | Tirat HaKarmel Mental Health Center | Principal Investigator |
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Be'er Sheva Mental Health Center, Tirat HaKarmel Mental Health Center | Be'er Sheva, Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20964499 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| D020912 | Moclobemide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002723 | Chlorobenzoates |