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Completed

NCT Number: NCT00951418

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cognitive function measured by CANTAB

    Time frame: once

Secondary outcomes

  1. T-wave morphology

    Time frame: Once

  2. Sedation VAS,ACES and SWAI scale

    Time frame: once

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Aug 4, 2009
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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