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| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | September 24, 2007 | ||||||||||||||||||||||||
| Last Updated Date | November 23, 2009 | ||||||||||||||||||||||||
| Start Date ICMJE | November 2008 | ||||||||||||||||||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: every two days ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00534573 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
CGI, NHRS [ Time Frame: two weeks ] | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation | ||||||||||||||||||||||||
| Official Title ICMJE | Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind | ||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||
| Condition ICMJE | Clozapine-induced Hypersalivation | ||||||||||||||||||||||||
| Intervention ICMJE | Drug: Amisulpride, Tiapride, Moclobemide | ||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||
| Publications * | |||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
| Enrollment ICMJE | 45 | ||||||||||||||||||||||||
| Completion Date | January 2009 | ||||||||||||||||||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years to 60 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT ID ICMJE | NCT00534573 | ||||||||||||||||||||||||
| Responsible Party | Prof. Vladimir Lerner, Beersheva Mental Health Center | ||||||||||||||||||||||||
| Study ID Numbers ICMJE | LCK4569, ISRCTN4569 | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Beersheva Mental Health Center | ||||||||||||||||||||||||
| Collaborators ICMJE | Tirat Carmel Mental Health Center | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Beersheva Mental Health Center | ||||||||||||||||||||||||
| Verification Date | November 2009 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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