Anticholinergic Burden in Schizophrenia

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Benztropine; Cholinergic Antagonists

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