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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.
 
ClinicalTrials.gov Identifier: NCT00951418
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date August 3, 2009
First Posted Date August 4, 2009
Last Update Posted Date September 12, 2013
Study Start Date June 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2009)
Cognitive function measured by CANTAB [ Time Frame: once ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 3, 2009)
  • T-wave morphology [ Time Frame: Once ]
  • Sedation VAS,ACES and SWAI scale [ Time Frame: once ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serum Clozapine and Cognition
Official Title Serum Clozapine and Cognition
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine
Condition Schizophrenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2013)
10
Original Estimated Enrollment
 (submitted: August 3, 2009)
100
Actual Study Completion Date September 2013
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00951418
Other Study ID Numbers 1.5-15 July 2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Rene Ernst Nielsen, M.D. Aalborg Psychiatric Hospital
PRS Account University of Aarhus
Verification Date August 2013