E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clozapine induced sinuatachycardia treated with bisoprolol. |
clozapin-induceret sinustakykardi |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013387 |
E.1.2 | Term | Disorganized type schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013386 |
E.1.2 | Term | Disorganised schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019364 |
E.1.2 | Term | Hebephrenic schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007780 |
E.1.2 | Term | Catatonic schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033872 |
E.1.2 | Term | Paranoid schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect of bisoprolol in treating clozapine induced sinustachycardia on surrogate marker heart rate variability |
Heart rate variability |
|
E.2.2 | Secondary objectives of the trial |
To investigate whether bisoprolol affects clozapine induced hypersalivatin and anxiety.
To investigate the effect of bisoprolol on ECG parameters. |
- subjektiv hypersalivation
- angst
- puls |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Both gender
Age 18-65 years
Treated with clozapine for minimum 3 months and minimum 100 mg/day
Fixed dose of antipsychotics and antidepressants during the last 14 days
Heart rate >100
Documentation that sinustachycardia was not present before clozapine
Pregnancy test negative
Sexual abstinence or birth control methods during the study and one month after |
|
E.4 | Principal exclusion criteria |
Significant substance misuse
Physical illness which demans precautions to treatment with clozapine and bisoprolol
Blood pressure <100/60 or dizziness causing fall
Administration of oral anticholinergics and carbamezapine
Treatment with betablocker 6 half-lives before inclusion or treatment with other cardiac medications (except acetylsalic acid or diuretics)
QT alterations (QTc>500 ms) SA or AV I and II
Retainment due to the mental health act.
Allergic to bisoprolol or clozapine. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Heart rate variability
Subjective Salivary rate |
- |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and after 7 days of treatment |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit af the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |