Serum Clozapine and Cognition

September 11, 2013 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive function measured by CANTAB
Time Frame: once
once

Secondary Outcome Measures

Outcome Measure
Time Frame
T-wave morphology
Time Frame: Once
Once
Sedation VAS,ACES and SWAI scale
Time Frame: once
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Rene Ernst Nielsen, M.D., Aalborg Psychiatric Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.5-15 July 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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