MedDataX Logo

Serum Clozapine and Cognition

NCT ID: NCT00951418

Last Updated: 2013-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

clozapine schizophrenia cognition t-wave morphology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rene Ernst Nielsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aalborg Psychiatric Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aalborg Psychiatric Hospital

Aalborg, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1.5-15 July 2008

Identifier Type: -

Identifier Source: org_study_id