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The effects of melatonin in the treatment of delirium- a double blind, randomized, placebo-controlled trial.


- candidate number5261
- NTR NumberNTR1657
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2009
- Secondary IDs2008-006452-22 EudraCTnumber
- Public TitleThe effects of melatonin in the treatment of delirium- a double blind, randomized, placebo-controlled trial.
- Scientific TitleThe effects of melatonin in the treatment of delirium- a double blind, randomized, placebo-controlled trial.
- ACRONYMMAPLE B
- hypothesisTo compare the differences in duration of delirium in delirious patients receiving anti-psychotic therapy + melatonin or anti-psychotic therapy + placebo.
- Healt Condition(s) or Problem(s) studiedDelirium, Elderly patients
- Inclusion criteria1. Age 65 years or older;
2. Acute hospital admission at medical ward;
3. Patients diagnosed with delirium for which anti-psychotic therapy is needed;
4. Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study;
5. Written informed consent must be obtained.
- Exclusion criteria1. Patients on medication that canít 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2009
- planned closingdate1-mei-2012
- Target number of participants200
- Interventionspatients receive anti-psychotics and melatonin or antipsychotics and placebo.
- Primary outcomeEvaluate possible differences in duration of delirium between patients receiving either anti-psychotics + melatonin or anti-psychotics + placebo.
- Secondary outcome1. 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 3 months 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.
- TimepointsDuring admission on each day of the study until the delirium is resolved with a maximum of twelve days. Three months and twelve months after discharge from the hospital.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. S.E. Rooij, de
- CONTACT for SCIENTIFIC QUERIESDr. S.E. Rooij, de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD4-feb-2009 - 9-aug-2013


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