Treating Clozapine-induced Sinustachycardia With Bisoprolol (Biscloz)

January 6, 2017 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital, Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bisoprolol-washout -placebo
Bisoprolol - wash out - placebo
Drug: Placebo
placebo
Drug: Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Other Names:
  • Bisoprolol "Vitabalans"
Active Comparator: Placebo - wash out - bisoprolol
Drug: Placebo
placebo
Drug: Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Other Names:
  • Bisoprolol "Vitabalans"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart rate variability
Time Frame: Baseline, visit 1+2+3
Baseline, visit 1+2+3

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aalborg University Hospital
Aalborg University

Investigators

  • Study Director: Ole Schjerning, M.D., Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-09215-22/5.1. 22AUG2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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