Condition category
Mental and Behavioural Disorders
Date applied
09/04/2008
Date assigned
16/05/2008
Last edited
04/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.admin.ox.ac.uk/rso/clinical

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

Publication citations

Additional files

Editorial Notes

On 04/03/2016 the overall trial end date was changed from 31/12/2009 to 29/06/2012.