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Metoclopramide as Treatment of Clozapine-induced Hypersalivation

NCT02222220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-08-21

No results posted yet for this study

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 treatment for this side effect.

Previous studies demonstrated that different medications from the substitute benzamide derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in general medicine). The investigators hypothesis assumes that anti-salivation effect characterizes the whole group of benzamide.

The aim of this study was to examine the efficacy of metoclopramide as an optional possibility for management of CIH.

Conditions

  • Clozapine-induced Hypersalivation

Interventions

DRUG

Metoclopramide

30 mg/day during 4 weeks

DRUG

placebo

Sponsors & Collaborators

  • Tirat Carmel Mental Health Center

    collaborator OTHER_GOV

  • Beersheva Mental Health Center

    lead OTHER_GOV

Principal Investigators

  • Vladimir Lerner, MD, PhD · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
57 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02222220 on ClinicalTrials.gov