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Completed

NCT Number: NCT00882856

Treating Clozapine-induced Sinustachycardia With Bisoprolol

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.

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Key information

Conditions

Clozapine-induced Sinustachycardia Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Psychiatry

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisoprolol

Drug

Bisoprolol "Vitabalnas" 10 mg once daily

Other names: Bisoprolol "Vitabalans"

Placebo

Drug

placebo

Primary outcomes

  1. Heart rate variability

    Time frame: Baseline, visit 1+2+3

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University
  • Aalborg University Hospital

Registry information

Official study title

Treating Clozapine-induced Sinustachycardia With Bisoprolol - a Double Blinded Placebo Controlled Cross Over Study

Acronym: Biscloz

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2009
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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