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Serum Clozapine and Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951418
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : September 12, 2013
Information provided by (Responsible Party):
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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Cross-Sectional
Official Title: Serum Clozapine and Cognition
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Primary Outcome Measures :
  1. Cognitive function measured by CANTAB [ Time Frame: once ]

Secondary Outcome Measures :
  1. T-wave morphology [ Time Frame: Once ]
  2. Sedation VAS,ACES and SWAI scale [ Time Frame: once ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951418

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Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
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Principal Investigator: Rene Ernst Nielsen, M.D. Aalborg Psychiatric Hospital
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Responsible Party: University of Aarhus Identifier: NCT00951418    
Other Study ID Numbers: 1.5-15 July 2008
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: August 2013
Keywords provided by University of Aarhus:
t-wave morphology
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders