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Anticholinergic Burden in Schizophrenia

NCT00715377 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-08-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Ariel Graff, MD · Centre for Addiction and Mental Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715377 on ClinicalTrials.gov