Melatonin In Acute Mania Investigation (MIAMI-uk)
| ISRCTN | ISRCTN28988273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28988273 |
| EudraCT/CTIS number | 2008-000281-23 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/04/2008
- Registration date
- 16/05/2008
- Last edited
- 21/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
digby.quested@psych.ox.ac.uk
Contact information
Scientific
Warneford Hospital
Headington
Oxford
OX37JX
United Kingdom
| Phone | +44 (0)1865 223703 |
|---|---|
| digby.quested@psych.ox.ac.uk |
Study information
| Study design | Double-blind randomised controlled phase 2 trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Melatonin In Acute Mania Investigation (MIAMI-uk): a randomised controlled phase 2 trial |
| Study acronym | MIAMI-uk |
| Study objectives | Melatonin as a possible treatment for mania. |
| Ethics approval(s) | Ethics Committee Oxford REC A, 04/09/2009, ref: 09/H0604/63 |
| Health condition(s) or problem(s) studied | Bipolar disorder |
| Intervention | Melatonin (circadin) 2 mg tablet orally at night 1 hour 30 min before sleep, or placebo for 21 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure | Young Mania Rating Scale at baseline, days 4, 7, 14 and 21. |
| Secondary outcome measures | 1. Activity on the Actiwatch to continue for 21 days 2. Quick Inventory of depressive symptoms C16 (Clinician) at baseline, days 4, 7, 14 and 21 3. Quick Inventory of depressive symptoms SR16 (self report) at baseline, days 4, 7, 14 and 21 4. Altman mania rating scale at baseline, days 4, 7, 14 and 21 5. Adverse events. Duration of follow-up: 21 days 6. Leeds Sleep Evaluation Questionnaire (LSEQ), carried out at baseline, day 4, day 7, day 14 and day 21 |
| Overall study start date | 01/07/2008 |
| Completion date | 29/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 41 |
| Key inclusion criteria | 1. Age limit from 18 to 65, both genders 2. Young Mania Rating Scale >=20 3. In or out-patients meeting the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM4) criteria for bipolar disorder 4. Currently experiencing manic symptoms 5. Capacity to give informed consent |
| Key exclusion criteria | 1. Clinically significant substance abuse 2. Comorbid Axis 1 disorders (DSM4) |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX37JX
United Kingdom
Sponsor information
University/education
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
| Website | http://www.admin.ox.ac.uk/rso/clinical |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 30/04/2018: Results presented at British Association of Psychopharmacology Conference 2013 https://www.bap.org.uk/pdfs/BAP2013_abstractbook.pdf (page 26) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/04/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/04/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
30/04/2018: Conference proceedings were added to the publication and dissemination plan.
04/03/2016: the overall trial end date was changed from 31/12/2009 to 29/06/2012.
