Treating Clozapine-induced Sinustachycardia With Bisoprolol

NCT ID: NCT00882856

Last Updated: 2017-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Clozapine-induced Sinustachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bisoprolol-washout -placebo

Bisoprolol - wash out - placebo

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

Bisoprolol "Vitabalnas" 10 mg once daily

Placebo

Intervention Type DRUG

placebo

Placebo - wash out - bisoprolol

Placebo - wash out - bisoprolol

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

Bisoprolol "Vitabalnas" 10 mg once daily

Placebo

Intervention Type DRUG

placebo

Interventions

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Bisoprolol

Bisoprolol "Vitabalnas" 10 mg once daily

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Bisoprolol "Vitabalans"

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ole Schjerning, M.D.

Role: STUDY_DIRECTOR

Aalborg University Hospital

Locations

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Aalborg University Hospital, Psychiatry

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-09215-22/5.1. 22AUG2011

Identifier Type: -

Identifier Source: org_study_id

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