Serum Clozapine and Cognition
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00951418
- Lead Sponsor
- University of Aarhus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive function measured by CANTAB once
- Secondary Outcome Measures
Name Time Method T-wave morphology Once Sedation VAS,ACES and SWAI scale once
Trial Locations
- Locations (1)
Aalborg Psychiatric Hospital
🇩🇰Aalborg, Denmark