Treating Clozapine-induced Sinustachycardia With Bisoprolol

Study Overview
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Brief Summary
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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.

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

Conditions
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Clozapine-induced Sinustachycardia

Intervention / Treatment
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* Drug: Bisoprolol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bisoprolol-washout -placebo<br>Bisoprolol - wash out - placebo | Drug: Bisoprolol<br>* Bisoprolol Vitabalnas 10 mg once daily<br>* Other names: Bisoprolol Vitabalans;Drug: Placebo<br>* placebo<br>|
| Active Comparator: Placebo - wash out - bisoprolol<br>Placebo - wash out - bisoprolol | Drug: Bisoprolol<br>* Bisoprolol Vitabalnas 10 mg once daily<br>* Other names: Bisoprolol Vitabalans;Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability |  | Baseline, visit 1+2+3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc, T-wave morphology and other ECG markers |  | Baseline, visit 1+2+3 | 
| Hamilton-Anxiety scale |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clozapine, Sinustachycardia, Heartrate variability, Cardiomyopathy