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Serum Clozapine and Cognition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00951418
First Posted: August 4, 2009
Last Update Posted: September 12, 2013
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.
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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
Schizophrenia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Serum Clozapine and Cognition

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

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

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

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: September 2013
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00951418


Locations
Denmark
Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Rene Ernst Nielsen, M.D. Aalborg Psychiatric Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00951418     History of Changes
Other Study ID Numbers: 1.5-15 July 2008
First Submitted: August 3, 2009
First Posted: August 4, 2009
Last Update Posted: September 12, 2013
Last Verified: August 2013

Keywords provided by University of Aarhus:
clozapine
schizophrenia
cognition
t-wave morphology

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents