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Treating Clozapine-induced Sinustachycardia With Bisoprolol (Biscloz)

This study is currently recruiting participants.
Verified February 2013 by University of Aarhus
Sponsor:
Collaborators:
Aalborg Universityhospital
Aalborg University
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00882856
First received: April 16, 2009
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

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 2014
Estimated Primary Completion Date: December 2014 (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
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
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882856

Contacts
Contact: Jimmi Nielsen, M.D. +4525779926 jin@rn.dk

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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00882856     History of Changes
Other Study ID Numbers: 2009-09215-22/5.1. 22AUG2011
Study First Received: April 16, 2009
Last Updated: February 11, 2013
Health Authority: Denmark: National Board of Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Clozapine
Sinustachycardia
Heartrate variability
Cardiomyopathy

Additional relevant MeSH terms:
Clozapine
Bisoprolol
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
GABA Antagonists
GABA Agents
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 23, 2013