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NCT00951418 Clinical Trial

Serum Clozapine and Cognition

Schizophrenia Clinical Trial

Official title:
Serum Clozapine and Cognition

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00951418
Other study ID # 1.5-15 July 2008
Secondary ID
Status Completed
Phase N/A
First received August 3, 2009
Last updated September 11, 2013
Start date June 2009
Est. completion date September 2013

Study information
Verified date August 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2013
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aalborg Psychiatric Hospital Aalborg

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cognitive function measured by CANTAB once No
Secondary T-wave morphology Once Yes
Secondary Sedation VAS,ACES and SWAI scale once No
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