Treating Clozapine-induced Sinustachycardia With Bisoprolol (Biscloz)

University of Aarhus

Status: Completed

Conditions: Clozapine-induced Sinustachycardia

Treatments: Drug: Bisoprolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00882856

2009-09215-22/5.1. 22AUG2011

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups

Bisoprolol-washout -placebo

Active Comparator group

Description:

Bisoprolol - wash out - placebo

Treatment:

Drug: Placebo

Drug: Bisoprolol

Placebo - wash out - bisoprolol

Active Comparator group

Description:

Placebo - wash out - bisoprolol

Treatment:

Drug: Placebo

Drug: Bisoprolol