Woman and Man
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Extract
Background and study aims Acute mania or a milder form called hypomania are ways in which bipolar disorder (manic depression) presents. Patients often require hospitalisation and usually require drug treatment with anti-psychotic drugs and mood stabilisers as well as valium-like tranquilisers. The main symptoms include over-activity, racing thoughts, grandiose beliefs and sleep loss. Melatonin is a naturally occurring hormone in the human body which is produced in darkness and suppressed by light. In animal studies it has been shown to inform body tissues about seasonal and light/dark information. In previous studies it caused an improvement in manic symptoms. A further small study of five people showed no effect but was too small a study to answer whether melatonin helps for mania/hypomania. In view of the above it is proposed that melatonin could help as a treatment for acute episodes of mania. Who can participate? Manic or hypomanic individuals aged from 18 to 65. What does the study involve? Participants will be randomly allocated to take either a melatonin (circadin) tablet or a placebo (dummy) tablet every night 1 hour 30 minutes before sleep for 21 days. Mood and sleep rating scales would be used to assess the progress of the patients on the treatments as well as a special watch which picks up levels of activity and sleep, called an Actiwatch. We will also test if melatonin can improve sleep in this group and reduce overactivity. What are the possible benefits and risks of participating? We would expect to see early sleep improvements as well as improvement in other symptoms on a more gradual basis in the group taking melatonin. If successful, it is hoped that early use of melatonin might enable some people to stay out of hospital for their period of relapse and get well sooner. Where is the study run from? University of Oxford (UK) When is the study starting and how long is it expected to run for? July 2008 to December 2009 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Digby Quested [email protected]
Inclusion criteria
- Bipolar disorder