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Clozapine-induced Hypersalivation - Feasibility Trial

NCT02613494 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-02-28

No results posted yet for this study

Summary

A randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the treatment of clozapine-induced hypersalivation to assess recruitment and retention rates in a multi-centre trial.

Conditions

  • Sialorrhea

Interventions

DRUG

Hyoscine

300 micrograms twice daily, increasing to 300 micrograms three times daily

DRUG

Glycopyrrolate

1 milligram twice daily, increasing to 1 milligram three times daily

OTHER

Placebo

Placebo twice daily, increasing to placebo three times daily

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • University of Central Lancashire

    collaborator OTHER

  • Manchester Mental Health & Social Care Trust

    collaborator OTHER_GOV

  • Lancashire Care NHS Foundation Trust

    collaborator NETWORK

  • Mersey Care NHS Trust

    lead OTHER

Principal Investigators

  • Inti Qurashi, MBChB · Mersey Care NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-25
Primary Completion
2017-12-31
Completion
2018-02-23

Countries

  • United Kingdom

Study Locations

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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 NCT02613494 on ClinicalTrials.gov