Status:

COMPLETED

Metoclopramide as Treatment of Clozapine-induced Hypersalivation

Lead Sponsor:

Beersheva Mental Health Center

Collaborating Sponsors:

Tirat Carmel Mental Health Center

Conditions:

Clozapine-induced Hypersalivation

Eligibility:

All Genders

19-57 years

Phase:

PHASE3

Brief Summary

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no effective enough tr...

Detailed Description

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy that may persist for several years. This side effect is usually dose-rela...

Eligibility Criteria

Inclusion

  • Age 18-60 years, male or female
  • DSM-IV criteria for schizophrenia
  • Clozapine treatment
  • At least score \>2 on the Nocturnal Hypersalivation Rating Scale (NHRS)

Exclusion

  • Evidence of organic brain damage, mental retardation, alcohol or drug abuse
  • Patients suffering from pheochromocytoma
  • Patients suffering from Parkinson's disease

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT02222220

Start Date

January 1 2012

End Date

May 1 2014

Last Update

August 21 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Be'er Sheva Mental Health Center,

Beersheba, Israel, 8417000