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Treating Clozapine-induced Sinustachycardia With Bisoprolol (Biscloz)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882856
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : January 9, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Clozapine-induced Sinustachycardia Drug: Bisoprolol Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study
Study Start Date : April 2009
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: Baseline, visit 1+2+3 ]

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882856


Locations
Denmark
Aalborg University Hospital, Psychiatry
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Aalborg Universitetshospital
Aalborg University
Investigators
Study Director: Ole Schjerning, M.D. Aalborg Universitetshospital
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00882856     History of Changes
Other Study ID Numbers: 2009-09215-22/5.1. 22AUG2011
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

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
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents