Treating increased haeart rate caused by clozapine

“Treating clozapine-induced sinustachycardia (BISCLOZ).” - BISCLOZ

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009215-22-DK

Enrollment

Registered

2009-02-23

Start date

2009-03-26

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Clozapine induced sinuatachycardia treated with bisoprolol. MedDRA version: 15.1 Level: LLT Classification code 10013387 Term: Disorganized type schizophrenia System Organ Class: 100000004873 MedDRA version: 15.1 Level: LLT Classification code 10013386 Term: Disorganised schizophrenia System Organ Class: 100000004873 MedDRA version: 15.1 Level: LLT Classification code 10019364 Term: Hebephrenic schizophrenia System Organ Class: 100000004873 MedDRA version: 15.1 Level: LLT Classification code

Interventions

Trade Name: Bisoprolol "Vitabalans" Product Name: Bisoprolol "Vitabalans" Product Code: 24726 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Both gender Age 18-65 years Treated with clozapine for minimum 3 months and minimum 100 mg/day Fixed dose of antipsychotics and antidepressants during the last 14 days Heart rate >100 Documentation that sinustachycardia was not present before clozapine Pregnancy test negative Sexual abstinence or birth control methods during the study and one month after Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Significant substance misuse Physical illness which demans precautions to treatment with clozapine and bisoprolol Blood pressure 500 ms) SA or AV I and II Retainment due to the mental health act. Allergic to bisoprolol or clozapine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of bisoprolol in treating clozapine induced sinustachycardia on surrogate marker heart rate variability;Secondary Objective: To investigate whether bisoprolol affects clozapine induced hypersalivatin and anxiety. To investigate the effect of bisoprolol on ECG parameters.;Primary end point(s): Heart rate variability Subjective Salivary rate;Timepoint(s) of evaluation of this end point: Baseline and after 7 days of treatment	—

Measure

Time frame

Main Objective: To investigate the effect of bisoprolol in treating clozapine induced sinustachycardia on surrogate marker heart rate variability;Secondary Objective: To investigate whether bisoprolol affects clozapine induced hypersalivatin and anxiety. To investigate the effect of bisoprolol on ECG parameters.;Primary end point(s): Heart rate variability Subjective Salivary rate;Timepoint(s) of evaluation of this end point: Baseline and after 7 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026