Serum Clozapine and Cognition
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Aarhus
First received: August 3, 2009
Last updated: November 6, 2012
Last verified: November 2012
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.
||Time Perspective: Cross-Sectional
||Serum Clozapine and Cognition
Primary Outcome Measures:
- Cognitive function measured by CANTAB [ Time Frame: once ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- T-wave morphology [ Time Frame: Once ] [ Designated as safety issue: Yes ]
- Sedation VAS,ACES and SWAI scale [ Time Frame: once ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine
- Treated with clozapine for minimum 6 months.
- Fixed dosage of clozapine last month before inclusion.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951418
|Aalborg Psychiatric Hospital
|Aalborg, Denmark, 9000 |
University of Aarhus
||Rene Ernst Nielsen, M.D.
||Aalborg Psychiatric Hospital
No publications provided
||University of Aarhus
History of Changes
|Other Study ID Numbers:
||1.5-15 July 2008
|Study First Received:
||August 3, 2009
||November 6, 2012
||Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Keywords provided by University of Aarhus:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Schizophrenia and Disorders with Psychotic Features
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents