Melatonin in Acute Mania Investigation Version 3.0

• Research type

  Research Study

• Full title

  Melatonin in Acute Mania Investigation (MIAMI-UK)

• IRAS ID

  17763

• Sponsor organisation

  University of Oxford

• Eudract number

  2008-000281-23

• ISRCTN Number

  28988273

• Research summary

  Acute mania or the less severe form - hypomania, are ways in which bipolar disorder can present. Patients often require hospitalisation and treatment with anti-psychotic drugs, hypnotics and mood stabilising medication. The symptoms include reduced sleep, over-activity, racing thoughts, and grandiose beliefs. Melatonin is a naturally occurring hormone, produced in a small gland in the brain (pineal) during darkness and suppressed in light. In animal studies it has been shown to inform bodily tissues about seasonal and light/dark phase information. In human studies it helped insomnia in 11 manic adolescents and in a single reported case melatonin benefitted a boy with early onset mania. A further small study in 5 rapid cycling manic individuals showed no beneficial effect but the sample size was very small. In view of the above it has been questioned whether melatonin could help as a treatment in acute episodes of hypomania or mania. It would be tested in a group of manic or hypomanic individuals both at home or in hospital and we might see sleep improvements as well as loss of the other symptoms, on a gradual basis, in the group taking melatonin. However it would be compared with a control group taking placebo (dummy) tablets on a random basis, with both the clinicians and patients blind to the treatment in a randomised controlled trial. Existing rating scales would be used to assess the patients on the treatments as well as an 'Actiwatch' which picks up levels of activity and sleep. We are investigating whether melatonin will improve symptoms. Early use of melatonin might enable relapsing patients to avoid hospital admission or additional medication. The study is being funded by the National Institute for Health Research and will be carried out at the Warneford Hospital in Oxford. Participants will be recruited from Oxfordshire and Buckinghamshire.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/63

• Date of REC Opinion

  4 Sep 2009

• REC opinion

  Further Information Favourable Opinion