Treating Clozapine-induced Sinustachycardia With Bisoprolol

Not Applicable

Completed

• Conditions: Clozapine-induced Sinustachycardia
• Interventions: Drug: Bisoprolol; Drug: Placebo

• Registration Number: NCT00882856
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bisoprolol-washout -placebo	Placebo	Bisoprolol - wash out - placebo
Placebo - wash out - bisoprolol	Placebo	Placebo - wash out - bisoprolol
Bisoprolol-washout -placebo	Bisoprolol	Bisoprolol - wash out - placebo
Placebo - wash out - bisoprolol	Bisoprolol	Placebo - wash out - bisoprolol

Primary Outcome Measures

Name	Time	Method
Heart rate variability	Baseline, visit 1+2+3

Secondary Outcome Measures

Name	Time	Method
QTc, T-wave morphology and other ECG markers	Baseline, visit 1+2+3
Salivation rate	Baseline, visit 1+2+3
Orthostatic blood pressure	Baseline, visit 1+2+3
WHO-QoL	Baseline, visit 1+2+3
Nocturnal Hypersalivation Rating Scale (NHRS).	Baseline, visit 1+2+3
Hamilton-Anxiety scale	Baseline, visit 1+2+3

Trial Locations

Locations (1)

Aalborg University Hospital, Psychiatry; 🇩🇰 Aalborg, Denmark