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Serum Clozapine and Cognition

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00951418
First received: August 3, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

Further study details as provided by University of Aarhus:

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: 100
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00951418     History of Changes
Other Study ID Numbers: 1.5-15 July 2008
Study First Received: August 3, 2009
Last Updated: November 6, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on June 17, 2013