Treating increased haeart rate caused by clozapine

Phase 1

• Conditions: Clozapine induced sinuatachycardia treated with bisoprolol.; MedDRA version: 15.1Level: LLTClassification code 10013387Term: Disorganized type schizophreniaSystem Organ Class: 100000004873; MedDRA version: 15.1Level: LLTClassification code 10013386Term: Disorganised schizophreniaSystem Organ Class: 100000004873; MedDRA version: 15.1Level: LLTClassification code 10019364Term: Hebephrenic schizophreniaSystem Organ Class: 100000004873; MedDRA version: 15.1Level: LLTClassification code 10007780Term: Catatonic schizophreniaSystem Organ Class: 100000004873; MedDRA version: 15.1Level: LLTClassification code 10033872Term: Paranoid schizophreniaSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-009215-22-DK
• Lead Sponsor: Aalborg Psychiatric Hospital, Centre for Skizophrenia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-23
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

Significant substance misuse
Physical illness which demans precautions to treatment with clozapine and bisoprolol
Blood pressure <100/60 or dizziness causing fall
Administration of oral anticholinergics and carbamezapine
Treatment with betablocker 6 half-lives before inclusion or treatment with other cardiac medications (except acetylsalic acid or diuretics)
QT alterations (QTc>500 ms) SA or AV I and II
Retainment due to the mental health act.
Allergic to bisoprolol or clozapine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>To investigate the effect of bisoprolol on ECG parameters.;Primary end point(s): Heart rate variability<br>Subjective Salivary rate;Timepoint(s) of evaluation of this end point: Baseline and after 7 days of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -