- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043925
QT-prolongation in Psychiatric Hospitals
July 27, 2015 updated by: Eline Vandael, KU Leuven
Observational study in 6 psychiatric hospitals in Flanders.
Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug.
An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval.
Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
152
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
-
-
-
Eeklo, Belgium
- Psychiatrisch Centrum Sint-Jan
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Observational study in 6 psychiatric hospitals in Flanders.
Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug.
Description
Inclusion Criteria:
- inpatient in one of the 6 participating psychiatric hospitals
- QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug
Exclusion Criteria:
- age < 18 year
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
psychiatric patients treated with QT-prolonging drugs
|
all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in QTc-interval (corrected for heart rate)
Time Frame: before and one week after the start of a QT-prolonging drug
|
before and one week after the start of a QT-prolonging drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
October 1, 2010
Primary Completion (ACTUAL)
March 1, 2015
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
January 21, 2014
First Submitted That Met QC Criteria
January 21, 2014
First Posted (ESTIMATE)
January 23, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 28, 2015
Last Update Submitted That Met QC Criteria
July 27, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VF/2010/02
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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