Serum Clozapine and Cognition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00951418
First received: August 3, 2009
Last updated: September 11, 2013
Last verified: August 2013

August 3, 2009
September 11, 2013
June 2009
March 2010   (final data collection date for primary outcome measure)
Cognitive function measured by CANTAB [ Time Frame: once ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00951418 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Serum Clozapine and Cognition
Serum Clozapine and Cognition

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine

Schizophrenia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2013
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00951418
1.5-15 July 2008
No
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Rene Ernst Nielsen, M.D. Aalborg Psychiatric Hospital
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP