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Serum Clozapine and Cognition

Serum Clozapine and Cognition

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00951418
Enrollment
10
Registered
2009-08-04
Start date
2009-06-30
Completion date
2013-09-30
Last updated
2013-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

clozapine, schizophrenia, cognition, t-wave morphology

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.

Interventions

None listed

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Cognitive function measured by CANTABonce

Secondary

MeasureTime frame
T-wave morphologyOnce
Sedation VAS,ACES and SWAI scaleonce

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026