The effects of melatonin in the treatment of delirium - MAPLE B
- Conditions
- Delirium in elderly patients (65 yrs and older) acutely admitted to the ward of internal medicine.MedDRA version: 9.1Level: LLTClassification code 10012218Term: Delirium
- Registration Number
- EUCTR2008-006452-22-NL
- Lead Sponsor
- Academic Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method