SchizophreniaNCT00951418
Serum Clozapine and Cognition
An observational study of Schizophrenia, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine
Who may be able to join
- Treated with clozapine for minimum 6 months.
- Fixed dosage of clozapine last month before inclusion.
Who cannot join
- 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.
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- Withdrawal of informed consent.
- Compulsory measures.
- Treatment with anticholinergics except for atropine drops administered sublingually.
- Changes in use of tobacco last month before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia
- Keywords
- clozapine, schizophrenia, cognition, t-wave morphology
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function measured by CANTAB
Measured: once
Secondary outcomes (2)
T-wave morphology
Measured: Once
Sedation VAS,ACES and SWAI scale
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Ernst Nielsen, M.D., Principal investigator, Aalborg Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951418
- Sponsor's protocol ID
- 1.5-15 July 2008
- Status last verified
- Aug 2013
- First submitted
- 3 Aug 2009
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Clozapine and Cognition
- ClinicalTrials.gov ID
- NCT00951418
- Acronym / sponsor ID
- 1.5-15 July 2008
- Conditions
- Schizophrenia
- Keywords
- clozapine, schizophrenia, cognition, t-wave morphology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine
Key inclusion criteria (2 listed)
- Treated with clozapine for minimum 6 months.
- Fixed dosage of clozapine last month before inclusion.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function measured by CANTAB
Time frame: once
2 secondary outcomes
T-wave morphology
Time frame: Once
Sedation VAS,ACES and SWAI scale
Time frame: once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Ernst Nielsen, M.D. principal investigator
Aalborg Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function measured by CANTAB (time frame: once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.