Melatonin In Acute Mania Investigation (MIAMI-uk)
Bipolar disorder can cause episodes of mania, where a person experiences high energy, racing thoughts, and severe sleep loss. These episodes are exhausting and often lead to hospital treatment. Researchers at the University of Oxford are investigating whether melatonin can help people recover faster. Melatonin is a natural hormone that the body releases in the dark to control sleep. In this study, adults aged 18 to 65 who are currently having a manic episode will take either a melatonin tablet or an inactive dummy pill (placebo) each night for 21 days. Participants will wear a lightweight wrist device called an Actiwatch to track their rest and activity levels, and they will complete regular mood questionnaires. The researchers hope that improving sleep will ease manic symptoms, reduce the need for heavy sedatives, and help people get well in the community rather than being admitted to hospital.
At a glance
What is this study about?
Bipolar disorder is a mental health condition characterised by extreme mood swings. During an episode of acute mania or hypomania, people often feel unusually energised, talk quickly, have racing thoughts, and sleep very little. These episodes can make daily life very difficult, and people frequently require hospital admission and strong medications to help stabilise their mood.
Good sleep is essential for mental health, but it is severely disrupted during mania. Melatonin is a hormone naturally made by the brain when night falls, acting as a signal that it is time to sleep. Earlier research suggests that melatonin might help settle manic symptoms by restoring natural body clocks. This trial aims to test that idea in a carefully controlled way.
By taking part, patients help doctors understand whether adding melatonin to standard care makes a real difference. If the treatment works, it could provide a simple, gentle way to help people regain normal sleep, manage mania more quickly, and avoid hospital admissions so they can recover at home.
Key takeaways
- The trial looks at whether melatonin can help treat acute mania in bipolar disorder.
- Participants take either melatonin or a dummy tablet each night for 21 days.
- Sleep and daily activity are tracked using a comfortable wrist device called an Actiwatch.
- Researchers hope improving sleep will calm manic symptoms and prevent hospital stays.
- Taking part is voluntary and does not replace your standard prescribed mental health medicines.
Who may be eligible?
This trial is open to men and women aged 18 to 65 who have a diagnosis of bipolar disorder and are currently experiencing an episode of mania or hypomania. Both people staying in a hospital ward and those receiving care in the community can be considered.
Participants must have symptoms active enough to meet the study's score criteria. Crucially, they must also have the mental capacity to understand what the research involves and give their own informed consent to join.
People cannot take part if they have significant problems with drug or alcohol abuse. The study also excludes anyone who has other major, separate psychiatric conditions that might make it hard to tell whether the treatment is working.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 65 years of age?
- Do you have a diagnosis of bipolar disorder?
- Are you currently having an episode of mania or hypomania?
- Can you understand the trial details and give informed consent?
- Are you free from significant alcohol or drug misuse problems?
What does participation involve?
Taking part in the trial lasts for 21 days (three weeks). Participants are randomly placed into one of two groups: one group takes a nightly melatonin tablet (Circadin) about 90 minutes before going to sleep, while the other takes a dummy tablet (placebo) that looks identical. Neither you nor your doctors will know which tablet you are taking during the study.
Throughout the three weeks, you will wear an Actiwatch, which looks like a normal wristwatch and records your sleep quality and movement patterns. You will also meet with researchers to complete straightforward questionnaires tracking your sleep, energy levels, and mood. After the 21 days of treatment, your participation ends, and you continue with your standard mental health care.
Potential risks and benefits
Locations (1)
- Warneford HospitalApproximateOxford, England
Common questions
What is melatonin?
Melatonin is a hormone produced naturally by your brain in the dark to help control your daily sleep and wake cycle.
Will I definitely receive the real melatonin tablet?
No. You have a 50% chance of receiving melatonin and a 50% chance of receiving a harmless dummy pill (placebo) to ensure fair test results.
What is an Actiwatch?
It is a small, lightweight device worn like a wristwatch that measures your daily physical activity and checks how well you sleep at night.
Do I have to stop taking my regular bipolar medication?
No. Melatonin is being tested alongside usual treatments, not as a replacement. You should never stop your prescribed medications.
Can I leave the study if I feel it is not right for me?
Yes. You can leave the trial at any point without giving a reason, and your regular NHS treatment will carry on as normal.
How to find out more
Digby Quested
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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