Condition category
Mental and Behavioural Disorders
Date applied
23/04/2008
Date assigned
19/06/2008
Last edited
27/03/2012
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 Barry Wright

ORCID ID

Contact details

Lime Trees Child
Adolescent & Family Unit
31 Shipton Road
York
YO30 5RF
United Kingdom
+44 (0)1904 726610
barry.wright@nyypct.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Melatonin will be better than placebo at improving time-to-onset of sleep (sleep latency) and total sleep time.

Ethics approval

York Research Ethics Committee. Date of Approval: 21/01/2004 (ref: 03/12/17)

Study design

Randomised controlled crossover trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep disorder in autism

Intervention

This is a crossover trial, with two arms: Melatonin medication vs placebo.

Group 1: One month no medication, 3 months melatonin, 1 month washout, 3 months placebo, 1 month no medication.
Group 2: One month no medication, 3 months placebo, 1 month washout, 3 months melatonin, 1 month no medication.

Melatonin (oral) started at 2 mg 30-40 minutes before planned sleep and increased every 3 nights by 2 mg to a maximum dose of 10 mg, titrating the dose to the response. If good sleep is achieved, the dose is kept at that level.

Intervention type

Drug

Phase

Not Specified

Drug names

Melatonin

Primary outcome measures

The following are recorded by the family every day from the beginning of the study for 9 months:
1. Sleep latency (i.e. time to onset of sleep)
2. Number of hours sleep per night (as recorded in daily sleep diaries)

Secondary outcome measures

The following are carried out at baseline and after 4, 8 and 9 months:
1. General Health Questionnaire
2. Sleep Difficulties Questionnaire (Likert scale)

Overall trial start date

01/04/2004

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both male and female children, aged 4-10 years
2. Diagnosis of typical or atypical childhood autism and sleep disorder (as defined by World Health Organization ICD-10 and sub-classified using the International Classification of Sleep Disorders)

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

32

Participant exclusion criteria

1. Children on any other medication including anti-epileptic medication
2. Children previously on melatonin or having any other sleep disorder treatments
3. Any families who do not complete sleep diaries during the one month lead-in period

Recruitment start date

01/04/2004

Recruitment end date

01/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lime Trees Child
York
YO30 5RF
United Kingdom

Sponsor information

Organisation

North Yorkshire and York Primary Care Trust (UK)

Sponsor details

c/o North Yorkshire Alliance R&D Unit
Learning & Research Centre
York District Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0)1904 726996
research.governance@york.nhs.uk

Sponsor type

Government

Website

http://www.nyypct.nhs.uk

Funders

Funder type

Government

Funder name

York Innovation Research Fund from the York and Selby Research and Development Committee, Selby and York Primary Care Trust. The Committee is currently represented by the North Yorkshire Research and Development Alliance (http://www.northyorksresearch.nhs.uk) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

London Law Trust (UK) (ref: 10/1/04)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20535539

Publication citations

  1. Results

    Wright B, Sims D, Smart S, Alwazeer A, Alderson-Day B, Allgar V, Whitton C, Tomlinson H, Bennett S, Jardine J, McCaffrey N, Leyland C, Jakeman C, Miles J, Melatonin versus placebo in children with autism spectrum conditions and severe sleep problems not amenable to behaviour management strategies: a randomised controlled crossover trial., J Autism Dev Disord, 2011, 41, 2, 175-184, doi: 10.1007/s10803-010-1036-5.

Additional files

Editorial Notes