Melatonin treatment for sleep problems in children with autism: a randomised controlled crossover trial

ISRCTN	ISRCTN77884120
DOI	https://doi.org/10.1186/ISRCTN77884120
Protocol serial number	N/A
Sponsor	North Yorkshire and York Primary Care Trust (UK)
Funders	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), London Law Trust (UK) (ref: 10/1/04)

Submission date: 23/04/2008
Registration date: 19/06/2008
Last edited: 27/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Barry Wright
Scientific

Lime Trees Child
Adolescent & Family Unit
31 Shipton Road
York
YO30 5RF
United Kingdom

Phone	+44 (0)1904 726610
Email	barry.wright@nyypct.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled crossover trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Melatonin will be better than placebo at improving time-to-onset of sleep (sleep latency) and total sleep time.
Ethics approval(s)	York Research Ethics Committee. Date of Approval: 21/01/2004 (ref: 03/12/17)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Melatonin
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	The following are carried out at baseline and after 4, 8 and 9 months: 1. General Health Questionnaire 2. Sleep Difficulties Questionnaire (Likert scale)
Completion date	01/11/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	10 Years
Sex	Not Specified
Target sample size at registration	32
Key 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)
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/11/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Lime Trees Child

York
YO30 5RF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes