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Treating Clozapine-induced Sinustachycardia With Bisoprolol (Biscloz)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by University of Aarhus
Aalborg Universitetshospital
Aalborg University
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: April 16, 2009
Last updated: August 8, 2016
Last verified: July 2016
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.

Condition Intervention
Clozapine-induced Sinustachycardia
Drug: Bisoprolol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QTc, T-wave morphology and other ECG markers [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: Yes ]
  • Hamilton-Anxiety scale [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: No ]
  • Salivation rate [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: No ]
  • Orthostatic blood pressure [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: Yes ]
  • WHO-QoL [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: No ]
  • Nocturnal Hypersalivation Rating Scale (NHRS). [ Time Frame: Baseline, visit 1+2+3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bisoprolol-washout -placebo
Bisoprolol - wash out - placebo
Drug: Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Other Name: Bisoprolol "Vitabalans"
Drug: Placebo
Active Comparator: Placebo - wash out - bisoprolol
Placebo - wash out - bisoprolol
Drug: Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Other Name: Bisoprolol "Vitabalans"
Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00882856

Contact: Jimmi Nielsen, M.D. +4525779926
Contact: Sonja Snel, M.D. +4597643563

Aalborg Psychiatric Hospital Recruiting
Aalborg, Denmark, 9000
Principal Investigator: Jimmi Nielsen, M.D.         
Sponsors and Collaborators
University of Aarhus
Aalborg Universitetshospital
Aalborg University
Principal Investigator: Jimmi Nielsen, PHD Aalborg Psychiatric Hospital
  More Information

Responsible Party: University of Aarhus Identifier: NCT00882856     History of Changes
Other Study ID Numbers: 2009-09215-22/5.1. 22AUG2011 
Study First Received: April 16, 2009
Last Updated: August 8, 2016
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The National Committee on Health Research Ethics

Keywords provided by University of Aarhus:
Heartrate variability

Additional relevant MeSH terms:
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents processed this record on December 02, 2016