Treating Clozapine-induced Sinustachycardia With Bisoprolol

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00882856

Acronym

Biscloz

Enrollment

Registered

2009-04-17

Start date

2009-04-30

Completion date

2016-12-31

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clozapine-induced Sinustachycardia

Keywords

Clozapine, Sinustachycardia, Heartrate variability, Cardiomyopathy

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.

Interventions

DRUGBisoprolol

Bisoprolol Vitabalnas 10 mg once daily

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Heart rate variability	Baseline, visit 1+2+3

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026