title: Moderate dose melatonin for the abatement and treatment of delirium in elderly general medical inpatients: study protocol of a placebo controlled, randomised, double blind trial.
abstract: BACKGROUND
  Delirium is a frequent, costly and morbid problem. No agent has been shown to modify the natural history of the condition, and current treatments have significant side effects. Prophylactic melatonin in low doses has been shown to prevent delirium developing. This trial then aims to determine the feasibility of a trial to assess if melatonin at a moderate dose effectively treats the symptoms of delirium and modifies the natural history, including abating symptoms after treatment cessation.
  
  
  METHODS
  Elderly (≥70 years of age) patients admitted to the Royal Melbourne Hospital with delirium, and not requiring surgery, will be identified from the current practice of the investigators and through referral by other general medical unit staff. To facilitate this, other staff will be briefed on the project by investigators. Patients will be recruited with suitable informed and documented consent (person responsible) by the study investigators. They will receive orally either 5 mg melatonin (18 patients) or placebo (18 patients) nightly for 5 nights (or until discharged). During treatment, participants will be assessed by study staff using a validated scale of delirium severity (the Memorial Delirium Assessment Scale), and a validated measure of delirium state (Confusion Assessment Method) to determine if melatonin decreases the severity or the duration of delirium. Assessment will continue for a further two days after treatment has ceased, to determine if the treatment causes persisting abatement of symptoms, and to assess for adverse events.
  
  
  CONCLUSIONS
  The on-going study described herein will contribute to our knowledge of available treatment options for elderly inpatients with delirium, where current pharmacological interventions show weak or no effect on hastening the resolution of delirium. As melatonin is safe, cheap, and potentially effective, it would be easily implementable in routine practice and could lead to significant outcome benefits for delirious inpatients.
  
  
  BACKGROUND
  The trial is registered with the Australia New Zealand Clinical Trials Registry (trial ID: ACTRN12614000101684 ) (registered 28/01/2014).
authors.affiliation: Alfred Health, Melbourne, VIC, Australia. chubb.daniel@gmail.com.|Department of Geriatrics, Royal Melbourne Hospital, Parkville, VIC, Australia. chubb.daniel@gmail.com.
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Clayton-Chubb
authors.affiliation: Department of Geriatrics, Royal Melbourne Hospital, Parkville, VIC, Australia.|Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Lange
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D002492:Central Nervous System Depressants / Q000008:administration & dosage; D003693:Delirium / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007297:Inpatients; D007902:Length of Stay; D008297:Male; D008550:Melatonin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D002492:Central Nervous System Depressants; D008550:Melatonin