Treating Clozapine-induced Sinustachycardia With Bisoprolol
NCT ID: NCT00882856
Last Updated: 2017-01-09
Study Results
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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COMPLETED
NA
21 participants
INTERVENTIONAL
2009-04-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Bisoprolol-washout -placebo
Bisoprolol - wash out - placebo
Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Placebo
placebo
Placebo - wash out - bisoprolol
Placebo - wash out - bisoprolol
Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Placebo
placebo
Interventions
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Bisoprolol
Bisoprolol "Vitabalnas" 10 mg once daily
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Aalborg University
OTHER
University of Aarhus
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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2009-09215-22/5.1. 22AUG2011
Identifier Type: -
Identifier Source: org_study_id
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