Anticholinergic Burden in Schizophrenia

This study has been terminated.
(Insufficient subject accrual)
Sponsor:
Information provided by (Responsible Party):
Ariel Graff, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00715377
First received: July 11, 2008
Last updated: April 15, 2012
Last verified: April 2012
  Purpose

Anticholinergic antiparkinsonian agents often cause side-effects including cognitive impairment, dry mouth, and constipation while they diminish antipsychotic-induced parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought fewer neurological side effects. However, anticholinergic coprescription rates are still as high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the established tradition of routine use of this medications. Older patients are particularly sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose of a frequently prescribed anticholinergics, benztropine, on cognitive function, extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic disorder.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Delusional Disorder
Psychotic Disorders
Drug: Benztropine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anticholinergic Burden in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • percentage of participants who successfully withdraw from anticholinergic antiparkinsonian agents. [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect of reducing the dose of benztropine on EPS and anticholinergic side-effects including cognitive impairments. [ Time Frame: intermittent ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2007
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Benztropine
Patients aged ≥ 50 years suffering from a primary psychotic disorder treated with a SGA and benztropine concomittantly at any dose steadily for at least 3 months will be eligible to participate in this study. The dose of benztropine will be reduced by 0.5mg per week. During this 8-week study period, extrapyramidal symptoms will be assessed on a weekly basis. The clinical assessments will be repeated 8 weeks after the initial assessments.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 50 and older
  • DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic disorder NOS
  • Having been treated with benztopine at a steady daily dose of 3 mg or less for at least three months
  • Having been treated with risperidone, quetiapine, olanzapine, or clozapine at a steady dose for at least two weeks.
  • Willingness to provide consent for investigator to communicate with their physician of record regarding their participation in the study.

Exclusion Criteria:

  • Unstable physical illness or clinically significant neurological disorder
  • A history of severe or life-threatening dystonia
  • Presence of EPS defined as a total score of 7 or more or a score of 3 or more on any individual item on the SAS at baseline
  • Positive urine drug screen for illegal drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715377

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Ariel Graff, MD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Ariel Graff, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00715377     History of Changes
Other Study ID Numbers: 118/2007
Study First Received: July 11, 2008
Last Updated: April 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
benztropine
Anticholinergic antiparkinsonian agents
antipsychotics
elderly population
side-effects

Additional relevant MeSH terms:
Schizophrenia, Paranoid
Delusions
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Antiparkinson Agents
Benztropine
Cholinergic Antagonists
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014