Metoclopramide as Treatment of Clozapine-induced Hypersalivation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02222220
• Date of registration: 17/08/2014
• Prospective Registration: No
• Primary sponsor: Beersheva Mental Health Center
• Public title: Metoclopramide as Treatment of Clozapine-induced Hypersalivation
• Scientific title: Metoclopramide as Treatment of Clozapine-induced Hypersalivation
• Date of first enrolment: January 2012
• Target sample size: 61
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02222220
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Israel

Contacts

• Name: Vladimir Lerner, MD, PhD
• Affiliation: Ben-Gurion University of the Negev

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- Evidence of organic brain damage, mental retardation, alcohol or drug abuse

- Patients suffering from pheochromocytoma

- Patients suffering from Parkinson's disease



Age minimum: 19 Years
Age maximum: 57 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Clozapine-induced Hypersalivation

Intervention(s)

Drug: Metoclopramide

Drug: placebo

Primary Outcome(s)

Nocturnal Hypersalivation Rating Scale (NHRS) [Time Frame: every week, up to 4 weeks]

Secondary Outcome(s)

Drooling Severity Scale (DSS) [Time Frame: every week, up to 4 weeks]

Secondary ID(s)

VLAK-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tirat Carmel Mental Health Center