Treating Clozapine-induced Sinustachycardia With Bisoprolol

Clozapine-induced Sinustachycardia Clinical Trial

— Biscloz  

Official title:

Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882856
• Other study ID #: 2009-09215-22/5.1. 22AUG2011
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: January 6, 2017
• Start date: April 2009
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Clozapine-induced sinustachycardia occurs in 25% of patients treated with clozapine and sustained sinustachycardia might be a risk factor for dilated cardiomyopathy. This double-blinded cross over placebo controlled study investigate whether 10 mg bisoprolol are efficient in treating clozapine-induced sinustachycardia measured as heart rate, heart rate variability, QTc and T-wave morphology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Treated with clozapine > 3 months and minimum 100 mg/day

• Fixed dose 14 days before inclusion

• Heart rate > 100 (ECG)

• Pregnancy test negative

• Clozapine-induced sinustachycardia documented by ECG or case record

• Sexual abstinence or contraception

• Informed consent

Exclusion Criteria:

• Substance abuse

• Physical diseases, contraindications for clozapine or bisoprolol

• Asthma or chronic obstructive lung disease

• Blood pressure < 100/60 or recent history of syncopes

• QTc>500 ms, SA-block, AV- block II or III

• Restrictions by Danish mental act

• Allergic to clozapine or bisoprolol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clozapine-induced Sinustachycardia

Intervention

Drug:
• Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
• Placebo
placebo

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital, Psychiatry	Aalborg

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital, Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability		Baseline, visit 1+2+3	No
Secondary	QTc, T-wave morphology and other ECG markers		Baseline, visit 1+2+3	Yes
Secondary	Hamilton-Anxiety scale		Baseline, visit 1+2+3	No
Secondary	Salivation rate		Baseline, visit 1+2+3	No
Secondary	Orthostatic blood pressure		Baseline, visit 1+2+3	Yes
Secondary	WHO-QoL		Baseline, visit 1+2+3	No
Secondary	Nocturnal Hypersalivation Rating Scale (NHRS).		Baseline, visit 1+2+3	No