Clinical Trial: Clozapine-induced Hypersalivation - Feasibility Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine

Brief 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.

Detailed Summary:

Primary objective

To assess the feasibility of recruiting both community and in-patients from different centres. Specifically, the feasibility study will:

  1. Ascertain whether the study design is acceptable to participants, including randomisation and use of telephone interviews.
  2. Ascertain whether the interventions are acceptable to participants and indicate likely attrition rates and tolerability.

Secondary objective

Ascertain the standard deviation of the daytime hypersalivation measure to estimate the required sample size for a future efficacy randomised clinical trial (RCT).

Study design

This is a multicentre (3 sites) randomised, double-blind, placebo-controlled feasibility study of glycopyrrolate and hyoscine in patients with clozapine-induced hypersalivation. Investigators will recruit 42 patients who have been prescribed clozapine and are experiencing hypersalivation. Eligible participants will be recruited to a 5-week study consisting of a 1-week wash-out period followed by a 4-week treatment period. Participants will be randomised on a 1:1:1 basis to one of three study arms (hyoscine, glycopyrrolate or placebo). Self-report measures of salivation and side effects will be taken weekly and cognition will be assessed on two occasions during the study.

Identification, recruitment and consenting of participants

Participants will be recruited from out-patient clozapine clinics from three National Health Service (NHS) mental health trusts. R&D approval
Sponsor: Mersey Care NHS Trust

Current Primary Outcome: Number of participants recruited and number of participants finishing the study [ Time Frame: Assessed at the end of the study (20 months after start of study) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Standard deviation of the daytime hypersalivation measure assessed by the Drooling Rating Scale (DRS) [ Time Frame: Assessed at the end of the study (20 months after start of study) ]

Standard deviation associated with the DRS measure that is observed in the participant sample


Original Secondary Outcome: Same as current

Information By: Mersey Care NHS Trust

Dates:
Date Received: October 21, 2015
Date Started: February 2016
Date Completion: September 2017
Last Updated: November 23, 2015
Last Verified: November 2015