Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Digby Quested
ORCID ID
Contact details
Warneford Hospital
Headington
Oxford
OX37JX
United Kingdom
+44 (0)1865 223703
digby.quested@psych.ox.ac.uk
Additional identifiers
EudraCT number
2008-000281-23
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Melatonin In Acute Mania Investigation (MIAMI-uk): a randomised controlled phase 2 trial
Acronym
MIAMI-uk
Study hypothesis
Melatonin as a possible treatment for mania.
Ethics approval
Ethics Committee Oxford REC A, 04/09/2009, ref: 09/H0604/63
Study design
Double-blind randomised controlled phase 2 trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Melatonin
Primary outcome measures
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 trial start date
01/07/2008
Overall trial end date
29/06/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Clinically significant substance abuse
2. Comorbid Axis 1 disorders (DSM4)
Recruitment start date
01/07/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warneford Hospital
Oxford
OX37JX
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research, Research for Innovation, Speculation and Creativity (RISC) programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary