NCT00951418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 12, 2013

Status Verified

August 1, 2013

Enrollment Period

9 months

First QC Date

August 3, 2009

Last Update Submit

September 11, 2013

Conditions

Schizophrenia

Keywords

clozapineschizophreniacognitiont-wave morphology

Outcome Measures

Primary Outcomes (1)

  • Cognitive function measured by CANTAB

    once

Secondary Outcomes (2)

  • T-wave morphology

    Once

  • Sedation VAS,ACES and SWAI scale

    once

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Treated with clozapine for minimum 6 months.

You may not qualify if:

  • Substance misuse.
  • Depression (Calgary Depression score ≥7).
  • Somatic disease that interfere with cognitive performance.
  • Electroconvulsive therapy.
  • Treatment with other antipsychotics.
  • Withdrawal of informed consent.
  • Compulsory measures.
  • Treatment with anticholinergics except for atropine drops administered sublingually.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Rene Ernst Nielsen, M.D.

    Aalborg Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

September 1, 2013

Last Updated

September 12, 2013

Record last verified: 2013-08

Locations

DK(1)