QT-prolongation in Psychiatric Hospitals

QT-prolongation Clinical Trial

Official title:

QT-prolongation in Psychiatric Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043925
• Other study ID #: VF/2010/02
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: July 27, 2015
• Start date: October 2010
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Long QT Syndrome
• QT-prolongation

Intervention

Drug:
• drugs linked with QT-prolongation
all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)

Locations

Country	Name	City	State
Belgium	Psychiatrisch Centrum Sint-Jan	Eeklo

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in QTc-interval (corrected for heart rate)		before and one week after the start of a QT-prolonging drug	Yes