E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Delirium in elderly patients admitted to the acute geriatric ward |
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E.1.1.1 | Medical condition in easily understood language |
Delirium (“acute confusional state”), characterized by an acute decline in attention and cognition, is a com-
mon clinical syndrome in elderly patients. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
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 |
The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium symptoms (measured by MDAS scores) in patients diagnosed with DSM-IV delirium (diagnosed by CAM). |
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E.2.2 | Secondary objectives of the trial |
We will study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
• Patient admitted to the acute, medical, geriatric ward
• Delirium or subsyndromal delirium diagnosed with CAM / MDAS within the last 48 hours
•Signed informed consent from patient or relatives and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/ local regulations. |
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E.4 | Principal exclusion criteria |
• Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree AV-block or any other reason causing HR <50 bpm at time of inclusion.
• Symptomatic hypotension or ortostatic hypotension, or a systolic BP <120 at the time of inclusion (after adequate rehydration).
• Reduced cerebral and/ or peripheral circulation due to vessel disease (ie manifest stroke within the last 3 months or critical peripheral ischemia).
• A diagnosis of polyneuropathy.
• Pheochromocytoma.
• Renal insufficiency (estimated GFR<30 ml/min according to the MDRD formula).
• Considered as moribund at admittance.
• Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
• Previously included in this study
• Adverse reactions to clonidine or excipients (lactose, saccharose)
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E.5 End points |
E.5.1 | Primary end point(s) |
Trajectory of delirium (severity and duration) measured by CAM and MDAS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At discharge from hospital |
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E.5.2 | Secondary end point(s) |
We will compare the actively treated group with the placebo group (also with subanalyses for subsyndromal delirium and hypoactive/hyperactive/mixed delirium) with respect to:
• Incidence of “full-scale” delirium, measured by CAM
• Severity of delirium, measured by MDAS
• Time-to-first delirium resolution
• Delirium subtype, measured by MDAS
• The use of “rescue medication”, as other sedatives, analgetics and antipsychotics
• Length of hospital stay
• Side effects of clonidine
• Pharmacokinetic/ pharmacodynamic response to clonidine
• Biomarkers
• Institutionalization
• Survival
• Cognitive function/ independence in follow-up after 4 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At discharge for hospital and 4 months after discharge from hospital |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.5 | 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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |