Anticholinergic Burden in Schizophrenia
This study has been terminated.
(Insufficient subject accrual)
Sponsor:
Centre for Addiction and Mental Health
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
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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
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 May 16, 2013