Treatment of delirium with clonidine
- Conditions
- Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]Delirium in elderly patients admitted to the acute geriatric ward
- Registration Number
- EUCTR2013-000815-26-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
• 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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).;Secondary Objective: 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. ;Primary end point(s): Trajectory of delirium (severity and duration) measured by CAM and MDAS;Timepoint(s) of evaluation of this end point: At discharge from hospital
- Secondary Outcome Measures
Name Time Method 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:<br>• Incidence of full-scale” delirium, measured by CAM<br>• Severity of delirium, measured by MDAS<br>• Time-to-first delirium resolution <br>• Delirium subtype, measured by MDAS<br>• The use of rescue medication”, as other sedatives, analgetics and antipsychotics<br>• Length of hospital stay<br>• Side effects of clonidine<br>• Pharmacokinetic/ pharmacodynamic response to clonidine<br>• Biomarkers<br>• Institutionalization<br>• Survival<br>• Cognitive function/ independence in follow-up after 4 months;Timepoint(s) of evaluation of this end point: At discharge for hospital and 4 months after discharge from hospital