Double-blind, randomized, placebo-controlled trial of metoclopramide for hypersalivation associated with clozapine

Anatoly Kreinin, Chanoch Miodownik, Vitaly Mirkin, Yulia Gaiduk, Yan Yankovsky, Yuly Bersudsky, Paul P. Lerner, Joseph Bergman, Vladimir Lerner

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4 Scopus citations

Abstract

Hypersalivation is a frequent, disturbing, and uncomfortable adverse effect of clozapine therapy that frequently leads to noncompliance. The aim of this study was to examine the efficacy ofmetoclopramide (dopamine D2 antagonist, antiemetic medication) as an option for management of hypersalivation associated with clozapine (HAC). A 3-week, double-blind, placebo-controlled trial was conducted in university-based research clinics from January 2012 to May 2014, on 58 inpatients treated with clozapine who were experiencing hypersalivation. The subjects were randomly divided into placebo and metoclopramide groups. The starting dose was 10 mg/d. Participants who did not respond were up-titrated 10 mg/d weekly to a total of 30 mg/d during the third week. The number of placebo capsuleswas increased accordingly up to 3 capsules per day. Primary outcome was the change from baseline to the end of study in the severity of hypersalivation as measured with the Nocturnal Hypersalivation Rating Scale and the Drooling Severity Scale. Secondary outcomes included ClinicalGlobal Impression of Improvement scale and adverse effect scales. Significant improvement on the Nocturnal Hypersalivation Rating Scale was demonstrated in the metoclopramide group from the end of the second week (P < 0.004), and on the Drooling Severity Scale (P < 0.02) in the third week. Clinical Global Impression-Improvement scale scores revealed major improvement. Twenty subjects (66.7%) treated with metoclopramide reported significant decline or total disappearance of HAC in comparison to 8 patients (28.6%) who received placebo (P = 0.031). No adverse effects to metoclopramide were reported. Metoclopramide was found to be safe and effective for the treatment of HAC.

Original languageEnglish
Pages (from-to)200-205
Number of pages6
JournalJournal of Clinical Psychopharmacology
Volume36
Issue number3
DOIs
StatePublished - 1 Jan 2016

Keywords

  • Hypersalivation associated with clozapine
  • Metoclopramide
  • Schizophrenia
  • Substitute benzamide
  • Treatment

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