Clozapine-induced SinustachycardiaBisclozNCT00882856
Treating Clozapine-induced Sinustachycardia With Bisoprolol
A study testing Bisoprolol in people with Clozapine-induced Sinustachycardia, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clozapine-induced Sinustachycardia
- What is being tested?
- Bisoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Clozapine-induced Sinustachycardia
- Being tested
- Bisoprolol, Placebo
- Keywords
- Clozapine, Sinustachycardia, Heartrate variability, Cardiomyopathy
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Also called Bisoprolol "Vitabalans"
Bisoprolol "Vitabalnas" 10 mg once daily
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol-washout -placebo | Active comparator | Bisoprolol - wash out - placebo Receives: Drug: Bisoprolol; Drug: Placebo |
| Placebo - wash out - bisoprolol | Active comparator | Placebo - wash out - bisoprolol Receives: Drug: Bisoprolol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: Baseline, visit 1+2+3
Secondary outcomes (6)
QTc, T-wave morphology and other ECG markers
Measured: Baseline, visit 1+2+3
Hamilton-Anxiety scale
Measured: Baseline, visit 1+2+3
Salivation rate
Measured: Baseline, visit 1+2+3
Orthostatic blood pressure
Measured: Baseline, visit 1+2+3
WHO-QoL
Measured: Baseline, visit 1+2+3
Nocturnal Hypersalivation Rating Scale (NHRS).
Measured: Baseline, visit 1+2+3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clozapine-induced SinustachycardiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University
- Responsible party
- Sponsor
- Investigators
- Ole Schjerning, M.D., Study director, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882856
- Sponsor's protocol ID
- 2009-09215-22/5.1. 22AUG2011
- Other IDs
- 2009
- Acronym
- Biscloz
- Status last verified
- Jan 2017
- First submitted
- 16 Apr 2009
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study
- ClinicalTrials.gov ID
- NCT00882856
- Acronym / sponsor ID
- Biscloz / 2009-09215-22/5.1. 22AUG2011
- Conditions
- Clozapine-induced Sinustachycardia
- Keywords
- Clozapine, Sinustachycardia, Heartrate variability, Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University
- Study start
- Apr 2009
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol-washout -placebo | Active comparator | Drug: Bisoprolol, Drug: PlaceboBisoprolol - wash out - placebo |
| Placebo - wash out - bisoprolol | Active comparator | Drug: Bisoprolol, Drug: PlaceboPlacebo - wash out - bisoprolol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololAlso: Bisoprolol "Vitabalans"Bisoprolol "Vitabalnas" 10 mg once daily | Drug | Bisoprolol-washout -placebo, Placebo - wash out - bisoprolol |
| Placeboplacebo | Drug | Bisoprolol-washout -placebo, Placebo - wash out - bisoprolol |
Primary outcome
Heart rate variability
Time frame: Baseline, visit 1+2+3
6 secondary outcomes
QTc, T-wave morphology and other ECG markers
Time frame: Baseline, visit 1+2+3
Hamilton-Anxiety scale
Time frame: Baseline, visit 1+2+3
Salivation rate
Time frame: Baseline, visit 1+2+3
Orthostatic blood pressure
Time frame: Baseline, visit 1+2+3
WHO-QoL
Time frame: Baseline, visit 1+2+3
Nocturnal Hypersalivation Rating Scale (NHRS).
Time frame: Baseline, visit 1+2+3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Schjerning, M.D. study director
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bisoprolol in people with Clozapine-induced Sinustachycardia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Baseline, visit 1+2+3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.