A Phase 3 interventional study of Amisulpride, Moclobemide in Clozapine-induced Hypersalivation, sponsored by Beersheva Mental Health Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-26.
Sponsored by Beersheva Mental Health Center · Phase 3, Interventional, and Treatment
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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 54 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →Beersheva Mental Health Center is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment during 2 weeks
Drug: Amisulpride, Moclobemide
Comparison
Drug: Amisulpride, Moclobemide
Drug pages: Amisulpride · Moclobemide
Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
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
Time frame: every two days
CGI, NHRS
CGI, NHRS
Time frame: two weeks
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amisulpride · Moclobemide
Beersheva Mental Health Center