Clozapine-induced Hypersalivation - Feasibility Trial

NCT02613494 | Completed Phase 1 DMC

• 1 other identifier: 2015-GOTHIC1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Sialorrhea

Keywords

clozapine; hypersalivation; refractory schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of participants recruited and number of participants finishing the study

  Assessed at the end of the study (20 months after start of study)

Secondary Outcomes (1)

• Standard deviation of the daytime hypersalivation measure assessed by the Drooling Rating Scale (DRS)

  Assessed at the end of the study (20 months after start of study)

Study Arms (3)

Hyoscine

ACTIVE COMPARATOR

Hyoscine hydrobromide

Drug: Hyoscine

Glycopyrrolate

ACTIVE COMPARATOR

Glycopyrronium bromide

Drug: Glycopyrrolate

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Hyoscine DRUG

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

Also known as: hyoscine hydrobromide

Hyoscine

Glycopyrrolate DRUG

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

Also known as: glycopyrronium bromide

Glycopyrrolate

Placebo OTHER

Placebo twice daily, increasing to placebo three times daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prescribed clozapine for a minimum of three months.
• Is experiencing hypersalivation (minimum score of 4 on the Drooling Rating Scale).
• Aged between 18 and 65 years and English speaking.
• Is capable of understanding the information given and provides informed consent prior to study specific procedures.

You may not qualify if:

• Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson's Disease).
• Neurological conditions that could affect cognitive functioning during the course of the study (e.g. unstable epilepsy)
• History of an allergic reaction to hyoscine hydrobromide or glycopyrrolate.
• Any of the following contra-indications to hyoscine or glycopyrrolate as stated in the British National Formulary: prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, toxic megacolon.
• Any of the following cautions to hyoscine or glycopyrrolate as stated in the British National Formulary e.g. closed angle glaucoma, chronic heart failure, chronic lung disease, untreated stomach ulcer, ulcerative colitis, significant liver problems, significant kidney disease, Downs Syndrome, persistent untreated tachycardia, overactive thyroid gland.
• Current prescription for potassium chloride, digoxin, cimetidine, indacaterol, amantadine, atenolol, levodopa or medications that, in the view of the trial pharmacist, have a significant anticholinergic profile.
• A woman of childbearing potential who has tested negative for pregnancy, unable or unwilling to use contraception during the study.
• Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
• Active suicidal ideation.
• Lack of capacity to provide informed consent. -

Sponsors & Collaborators

• Mersey Care NHS Trust: lead
• University of Manchester: collaborator
• University of Central Lancashire: collaborator
• Manchester Mental Health & Social Care Trust: collaborator
• Lancashire Care NHS Foundation Trust: collaborator

Study Sites (2)

Lancashire Care NHS Foundation Trust

Preston, Lancashire, United Kingdom

Location

Mersey Care NHS Trust

Liverpool, Merseyside, United Kingdom

Location

Related Publications (2)

• Qurashi I, Chu S, Drake R, Hartley V, Chaudhry I, Deakin JFW, Husain N. Glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of hypersalivation induced by clozapine (GOTHIC1): a feasibility study. Pilot Feasibility Stud. 2019 Jun 17;5:79. doi: 10.1186/s40814-019-0462-1. eCollection 2019.

  PMID: 31236286 DERIVED

• Qurashi I, Chu S, Husain N, Drake RJ, Chaudhry I, Deakin JF. Glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of hypersalivation induced by clozapine (GOTHIC1): study protocol for a randomised controlled feasibility study. Trials. 2016 Nov 21;17(1):553. doi: 10.1186/s13063-016-1678-5.

  PMID: 27871302 DERIVED

MeSH Terms

Conditions

Sialorrhea; Schizophrenia, Treatment-Resistant

Interventions

Scopolamine; Butylscopolammonium Bromide; Glycopyrrolate

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Amines; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Inti Qurashi, MBChB

  Mersey Care NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: November 24, 2015
• Study Start: January 25, 2016
• Primary Completion: December 31, 2017
• Study Completion: February 23, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

GB (2)