Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marc Serfaty

ORCID ID

Contact details

Royal Free Hospital School of Medicine
University Department of Psychiatry
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7830 2293/7794 0500

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00970

Study information

Scientific title

Acronym

Study hypothesis

There has recently been a considerable growth of interest in the therapeutic potential of the pineal hormone melatonin. Exogenous low-dose melatonin has been shown to be a safe and effective treatment of conditions where there is a disturbance of the sleep-wake cycle. In elderly subjects without mental illness, melatonin is effective in treating sleep disturbance.
Disruption of sleep is especially common with reversal of the sleep-wake cycle. Not only does disruption of the sleep pattern cause considerable distress to patients, it is also one of the major problems encountered by carers. Indeed, a breakdown of care by relatives has significant economic implications. Since dementia is also associated with disturbance of circadian rhythm and exogenous melatonin is effective in entraining the sleep cycle in normal subjects, we propose a trial to test the hypothesis that exogenous low dose melatonin will improve sleep in elderly subjects with dementia.

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Dementia

Intervention

1. Low dose melatonin
2. Placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. An improvement in patents sleep quality and duration with melatonin compared with placebo.
2. An improvement in carers quality of life because if less disruption by restless patients.
3. A decrease in need for other more potent medications with significant side effects.
The main outcome measure used will be improvement in length of sleep and a decrease in periods of nocturnal wakening for the periods 10 pm and 8 am.
Objective measures will be made using a validated sleep activity and pulse logger (Somnitor) (Cole et al 1992).
Subsidiary outcome measures will include: recordings of sleep using a sleep diary ratings on quality of sleep using Visual Analogue Scales, carer rating scales and the use of prescribed hypnotic
medication.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/08/1998

Overall trial end date

03/09/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged over 65 years. Either gender.
2. Clinical Diagnostic Statistical Manual, IV edition (DSM-IV). Axix I diagnosis of dementia of Alzheimer's type.
3. Inpatients or patients living at home and managed by carers.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

03/08/1998

Recruitment end date

03/09/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital School of Medicine
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

2002 results in http://www.ncbi.nlm.nih.giv/pubmed/12461760

Publication citations

Additional files

Editorial Notes