E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Delirium in elderly patients (65 yrs and older) acutely admitted to the ward of internal medicine. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012218 |
E.1.2 | Term | Delirium |
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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 |
Evaluate possible differences in duration of delirium between patients receiving either anti-psychotics + melatonin or anti-psychotics + placebo. |
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E.2.2 | Secondary objectives of the trial |
1] Evaluate possible differences in severity of delirium between the anti-psychotics + melatonin group and the anti-psychotics + placebo group. 2] Compare possible differences in the length of hospital stay in delirious patients in the anti-psychotic + melatonin group or anti-psychotic + placebo group. 3] Evaluate possible differences in the total dose of additional benzodiazepines used to treat delirium in both the anti-psychotics + melatonin group and the anti-psychotics + placebo group. 4] Evaluate possible differences in the total dose of haloperidol used during the period of delirium in the anti-psychotics + melatonin group and the anti-psychotics + placebo group. 5] Evaluate the possible effects of delirium and of melatonin therapy on cognitive function 1 month and 12 months after hospital admission. 6] Evaluate possible effects of delirium and of melatonin therapy on functional decline, measured by grip-strength and by KATZ questionnaire.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1] Age 65 years or older 2] Acute hospital admission at medical ward 3] Patients diagnosed with delirium for which anti-psychotic therapy is needed. 3] Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study 4] Written informed consent must be obtained
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E.4 | Principal exclusion criteria |
1] Patients on medication that can’t speak or understand Dutch 2] Patients diagnosed with delirium who have received anti-psychotics longer than 24 hours. 3] Patients with a clinical diagnosis of hypoactive delirium
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E.5 End points |
E.5.1 | Primary end point(s) |
End of delirium, diagnosed by a negative Confusion Assesment Method (CAM-score) |
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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 | No |
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.8.3 |
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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
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After inclusion of 200 patients we will calcualte the effect size, blinded for treatment regiment. If we find an effect size smaller than 0.11, which matches a difference of one day with a SD of 9.2, we will stop the study due to futility. Then the trial will be ended pre-maturely. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |