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Trial record 31 of 185 for:    GLYCOPYRROLATE

Clozapine-induced Hypersalivation - Feasibility Trial (GOTHIC1)

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ClinicalTrials.gov Identifier: NCT02613494
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : February 28, 2018
Sponsor:
Collaborators:
University of Manchester
University of Central Lancashire
Manchester Mental Health & Social Care Trust
Lancashire Care NHS Foundation Trust
Information provided by (Responsible Party):
Mersey Care NHS Trust

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.

Condition or disease Intervention/treatment Phase
Sialorrhea Drug: Hyoscine Drug: Glycopyrrolate Other: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine
Actual Study Start Date : January 25, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hyoscine
Hyoscine hydrobromide
Drug: Hyoscine
300 micrograms twice daily, increasing to 300 micrograms three times daily
Other Name: hyoscine hydrobromide

Active Comparator: Glycopyrrolate
Glycopyrronium bromide
Drug: Glycopyrrolate
1 milligram twice daily, increasing to 1 milligram three times daily
Other Name: glycopyrronium bromide

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo twice daily, increasing to placebo three times daily




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson's Disease).
  2. Neurological conditions that could affect cognitive functioning during the course of the study (e.g. unstable epilepsy)
  3. History of an allergic reaction to hyoscine hydrobromide or glycopyrrolate.
  4. 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.
  5. 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.
  6. 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.
  7. A woman of childbearing potential who has tested negative for pregnancy, unable or unwilling to use contraception during the study.
  8. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
  9. Active suicidal ideation.
  10. Lack of capacity to provide informed consent. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613494


Locations
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United Kingdom
Lancashire Care NHS Foundation Trust
Preston, Lancashire, United Kingdom
Mersey Care NHS Trust
Liverpool, Merseyside, United Kingdom
Sponsors and Collaborators
Mersey Care NHS Trust
University of Manchester
University of Central Lancashire
Manchester Mental Health & Social Care Trust
Lancashire Care NHS Foundation Trust
Investigators
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Principal Investigator: Inti Qurashi, MBChB Mersey Care NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mersey Care NHS Trust
ClinicalTrials.gov Identifier: NCT02613494     History of Changes
Other Study ID Numbers: 2015-GOTHIC1
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Mersey Care NHS Trust:
clozapine
hypersalivation
refractory schizophrenia
Additional relevant MeSH terms:
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Glycopyrrolate
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Scopolamine
Bromides
Clozapine
Butylscopolammonium Bromide
Anticonvulsants
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Mydriatics