Serum Clozapine and Cognition

University of Aarhus10 enrolled

Overview

This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Schizophrenia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treated with clozapine for minimum 6 months. * Fixed dosage of clozapine last month before inclusion. Exclusion Criteria: * Substance misuse. * Depression (Calgary Depression score ≥7). * Somatic disease that interfere with cognitive performance. * Treatment with benzodiazepines (half-lives \>15 hours not allowed up 14 days prior inclusion and during study. Half-lives \< 15 hours not allowed 3 days prior cognitive testing). * Electroconvulsive therapy. * Treatment with other antipsychotics. * Withdrawal of informed consent. * Compulsory measures. * Treatment with anticholinergics except for atropine drops administered sublingually. * Changes in use of tobacco last month before inclusion.

Locations (1)

Aalborg Psychiatric Hospital

Aalborg, Denmark

Outcomes

Primary Outcomes

Cognitive function measured by CANTAB

Time frame: once

Secondary Outcomes

T-wave morphology

Time frame: Once

Sedation VAS,ACES and SWAI scale

Time frame: once

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.