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Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation (CIH)
This study has been completed.
Study NCT00534573   Information provided by Beersheva Mental Health Center
First Received: September 24, 2007   Last Updated: November 23, 2009   History of Changes

September 24, 2007
November 23, 2009
November 2008
January 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00534573 on ClinicalTrials.gov Archive Site
CGI, NHRS [ Time Frame: two weeks ]
Same as current
 
Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation
Comparison of Benzamide Derivates (Amisulpride, Moclobemide and Tiapride) as Treatment of Clozapine-induced Hypersalivation: Pilot Double Phase Study: Open and Double-blind

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Clozapine-induced Hypersalivation
Drug: Amisulpride, Tiapride, Moclobemide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
45
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00534573
Prof. Vladimir Lerner, Beersheva Mental Health Center
LCK4569, ISRCTN4569
Beersheva Mental Health Center
Tirat Carmel Mental Health Center
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
Beersheva Mental Health Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP