Treating Clozapine-induced Sinustachycardia With Bisoprolol | NCT00882856

Studies
Treating Clozapine-induced Sinustachycardia With Bisoprolol

NCT00882856

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 9, 2017Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Clozapine-induced Sinustachycardia

Interventions

Bisoprolol
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 16, 2009

First Submission Date that Met QC Criteria

Apr 16, 2009

First Posted Date

Apr 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2017

Last Update Posted Date

Jan 9, 2017Estimated

Name	Class
Aalborg University Hospital	OTHER
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bisoprolol-washout -placebo	Active Comparator	Bisoprolol - wash out - placebo	Drug: Bisoprolol Drug: Placebo
Placebo - wash out - bisoprolol	Active Comparator	Placebo - wash out - bisoprolol	Drug: Bisoprolol Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bisoprolol	Drug	Bisoprolol "Vitabalnas" 10 mg once daily	Bisoprolol-washout -placebo Placebo - wash out - bisoprolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate variability		Baseline, visit 1+2+3

Secondary Outcomes

Measure	Description	Time Frame
QTc, T-wave morphology and other ECG markers		Baseline, visit 1+2+3
Hamilton-Anxiety scale		Baseline, visit 1+2+3
Salivation rate

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ole Schjerning, M.D.	Aalborg University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital, Psychiatry		Aalborg		9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017298	Bisoprolol

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided