Anticholinergic Burden in Schizophrenia

NCT00715377 | Terminated

• 1 other identifier: 118/2007
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Delusional Disorder; Psychotic Disorders

Keywords

benztropine; Anticholinergic antiparkinsonian agents; antipsychotics; elderly population; side-effects

Outcome Measures

Primary Outcomes (1)

• percentage of participants who successfully withdraw from anticholinergic antiparkinsonian agents.

  at the end of the study

Secondary Outcomes (1)

• effect of reducing the dose of benztropine on EPS and anticholinergic side-effects including cognitive impairments.

  intermittent

Study Arms (1)

1

EXPERIMENTAL

Drug: Benztropine

Interventions

Benztropine DRUG

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.

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid

Interventions

Benztropine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Ariel Graff, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

CA (1)