Melatonin versus placebo in children with autism spectrum conditions and severe sleep problems not amenable to behaviour management strategies: A randomised controlled crossover trial

Journal of Autism and Developmental Disorders

Volumn 41, Issue 2, 2011, Pages 175-184

  Wright, Barry ^a   Sims, David ^b   Smart, Siobhan ^c   Alwazeer, Ahmed ^d   Alderson Day, Ben ^a   Allgar, Victoria ^e   Whitton, Clare ^a,g   Tomlinson, Heather ^a   Bennett, Sophie ^a   Jardine, Jenni ^a,h   McCaffrey, Nicola ^a,i   Leyland, Charlotte ^e   Jakeman, Christine ^f   Miles, Jeremy ^f,j  

^a Adolescent and Family Unit   (United Kingdom)

^b Hillbrook Child and Family Centre   (United Kingdom)

^c Dragon Parade Clinic   (United Kingdom)

^d ROYAL BOLTON HOSPITAL   (United Kingdom)

^e UNIVERSITY OF YORK   (United Kingdom)

^f YORK HOSPITAL   (United Kingdom)

^g Woodside Resource Centre   (United Kingdom)

^h TYNE AND WEAR NHS FOUNDATION TRUST   (United Kingdom)

ⁱ NHS GRAMPIAN   (United Kingdom)

^j RAND CORPORATION   (United States)

more..

Author keywords

Autism spectrum disorders; Dysomnia; Melatonin; Sleep

Indexed keywords

MELATONIN; PLACEBO;

ADOLESCENT; ALERTNESS; APPETITE; ARTICLE; AUTISM; BEHAVIOR THERAPY; CHILD; CLINICAL ARTICLE; CROSSOVER PROCEDURE; DAYTIME DROWSINESS; DEVELOPMENTAL BEHAVIOUR CHECKLIST; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DYSOMNIA; FEMALE; GENERAL HEALTH QUESTIONNAIRE; HUMAN; MALE; PARASOMNIA; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SCORING SYSTEM; SIDE EFFECT; SLEEP APNEA SYNDROME; SLEEP DISORDER; SLEEP TIME; SLEEP WAKING CYCLE; STRUCTURED QUESTIONNAIRE; TREATMENT RESPONSE;

ADOLESCENT; CENTRAL NERVOUS SYSTEM DEPRESSANTS; CHILD; CHILD DEVELOPMENT DISORDERS, PERVASIVE; CHILD, PRESCHOOL; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MELATONIN; QUESTIONNAIRES; SLEEP DISORDERS; TREATMENT OUTCOME;

EID: 78751641576     PISSN: 01623257     EISSN: 15733432     Source Type: Journal    
DOI: 10.1007/s10803-010-1036-5     Document Type: Article

References (59)

1. H Allik JO Larson H Smedje 2006 Sleep patterns of school age children with asperger syndrome or high functioning autism Journal of Autism and Developmental Disorders 36 585 595 10.1007/s10803-006-0099-9 16617404 (Pubitemid 44336981)
2. IM Andersen J Kaczmarska SG McGrew BA Malow 2008 Melatonin for insomnia in children with autism spectrum disorders Journal of Child Neurology 23 5 482 485 10.1177/0883073807309783 18182647 (Pubitemid 351566859)
3. D Armour C Paton 2004 Melatonin in the treatment of insomnia in children and adolescents Psychiatric Bulletin 28 222 224 10.1192/pb.28.6.222 (Pubitemid 38771869)
4. D Bramble C Feehan 2005 Psychiatrists' use of melatonin with children Child and Adolescent Mental Health 10 3 145 149 10.1111/j.1475-3588.2005.00358.x (Pubitemid 41702713)
5. N Buscemi B Vandermeer N Hooton R Pandya L Tjosvold L Hartling S Vohra TP Klassen G Baker 2006 Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis British Medical Journal 332 385 388 10.1136/bmj.38731.532766.F6 16473858 (Pubitemid 43797377)
6. P Camfield K Gordon J Dooley 1996 Melatonin appears ineffective in children with intellectual deficits and fragmented sleep: six 'N of 1' trials Journal of Child Neurology 11 341 343 10.1177/088307389601100414 8807426
7. G Coppola G Iervolino M Mastrosimone G La Torre F Ruiu A Pascotto 2004 Melatonin in wake sleep disorders in children, adolescents and young adults with mental retardation with and without epilepsy: A double blind, cross over placebo controlled trial Brain Development 26 6 373 376 10.1016/j.braindev.2003. 09.008 15275698 (Pubitemid 38953323)
8. Council Directive (EC) 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
9. RL DeMuro AN Nafziger DE Blask AM Menhinick JS Bertino 2000 The absolute bioavailability of oral melatonin The Journal of Clinical Pharmacology 40 781 784 10.1177/00912700022009422
10. S Dickerson Mayes SL Calhoun 2009 Variables related to sleep problems in children with autism Research in Autism Spectrum Disorders 3 4 931 941 10.1016/j.rasd.2009.04.002
11. NN Dodge GA Wilson 2001 Melatonin for treatment of sleep disorders in children with developmental disabilities Journal of Child Neurology 16 581 584 11510929
12. S Doo YK Wing 2006 Sleep problems of children with pervasive developmental disorders: Correlation with parental stress Developmental Medicine and Child Neurology 48 650 655 10.1017/S001216220600137X 16836776 (Pubitemid 44044467)
13. Einfield, S. L., & Tonge, B. J. (1989). The Developmental Behaviour Checklist. Melbourne Australia: Monash University Centre For Developmental Psyhciatry.
14. G Galli-Carminati N Deriaz G Bertschy 2009 Melatonin in the treatment of chronic sleep disorders in adults with autism: A retrospective study Swiss med weekly 139 19-20 293 296
15. J Garstang M Wallis 2006 Randomised controlled trial of melatonin for children with autistic spectrum disorders and sleep problems Child: Care, Health and Development 32 585 589 10.1111/j.1365-2214.2006.00616.x (Pubitemid 44210097)
16. F Giannotti F Cortesi A Cerquiglini P Bernabei 2006 An open label study of controlled release melatonin in treatment of sleep disorders in children with autism Journal of Autism and Developmental Disorders 36 741 752 10.1007/s10803-006-0116-z 16897403 (Pubitemid 44284978)
17. Goldberg, D. (1992). General health questionnaire (GHQ-12). Windsor, UK: Nfer-Nelson.
18. N Gordon 2000 The therapeutics of Melatonin: a paediatric perspective Brain and Development 22 213 217 10.1016/S0387-7604(00)00120-0 10838105 (Pubitemid 30323831)
19. E Hayashi 2000 Effect of melatonin on sleep-wake rhythm: The sleep diary of an autistic male Psychiatry and Clinical Neurosciences 54 3 383 10.1046/j.1440-1819.2000.00725.x 11186124 (Pubitemid 30431869)
20. E Hayashi 2001 Seasonal changes in sleep and behavioural problems in a prepubescent case with autism Psychiatry and Clinical Neurosciences 55 223 224 10.1046/j.1440-1819.2001.00833.x 11422849 (Pubitemid 32578356)
21. Y Hoshino H Watanabe Y Yashima M Kaneko H Kumashiro 1984 An investigation on the sleep disturbance of autistic children Folia Psychiatrica et Neurologica Japonica 38 45 51 6537391
22. A Ishizaki, et al. 1999 Usefulness of melatonin for developmental sleep and emotional/behavior disorders-studies of melatonin trial on 50 patients with developmental disorders No To Hattatsu 31 5 428 437 10487068
23. A Ivanenko VM Crabtree R Tauman, et al. 2003 Melatonin in children and adolescents with insomnia: a retrospective study Clinical Paediatrics 42 51 58 10.1177/000992280304200108
24. MS Jan, et al. 1994 The treatment of sleep disorders with melatonin Developmental Medicine and Child Neurology 36 97 107 10.1111/j.1469-8749.1994. tb11818.x 8132132
25. JE Jan RD Freeman DK Fast 1999 Melatonin treatment of sleep-wake cycle disorders in children and adolescents Developmental Medicine and Child Neurology 41 491 500 10.1017/S0012162299001061 10454235 (Pubitemid 29322492)
26. SW Lockley DJ Skene J Arendt H Tabandeh AC Bird R Defrance 1997 Relationship between melatonin rhythms and visual loss in the blind The Journal of Clinical Endocrinology and Metabolism 82 3763 3770 10.1210/jc.82.11.3763 9360538 (Pubitemid 27509369)
27. C Lord M Rutter A Le Couteur 1994 Autism diagnostic interview-revised: A revised version of a diagnostic interview for caregivers of individuals with possible pervasive developmental disorders Journal of Autism and Developmental Disorders 24 659 685 10.1007/BF02172145 7814313 (Pubitemid 24309810)
28. C Lord S Risi L Lambrecht EH Cook BL Leventhal PC DiLavore A Pickles M Rutter 2001 The autism diagnostic observation schedule-generic: A standard measure of social and communication deficits associated with the spectrum of autism Journal of Autism and Developmental Disorders 30 205 223 10.1023/A:1005592401947
29. BA Malow ML Marzec SG McGrew L Wang LM Henderson WL Stone 2006 Characterising sleep in children with autism spectrum disorders: A multidimensional approach Sleep 29 1563 1571 17252887
30. AJ McArthur SS Budden 1998 Sleep dysfunction in Rett syndrome: A trial of exogenous melatonin treatment Developmental Medicine and Child Neurology 40 3 186 192 10.1111/j.1469-8749.1998.tb15445.x 9566656
31. J Melke H Goubran-Botros P Chaste C Betancur G Nygren H Anckarsäter M Rastam O Ståhlberg C Gillberg R Delorme N Chabane M Mouren-Simeoni F Fauchereau C Durand F Chevalier X Drouot C Collet J Launay M Leboyer C Gillberg T Bourgeron the PARIS study 2008 Abnormal melatonin synthesis in autism spectrum disorders Molecular Psychiatry 13 1 90 98 10.1038/sj.mp.4002016 17505466 (Pubitemid 350275181)
32. K Minde A Faucon S Faulkner 1994 Sleep problems in toddlers, effects of treatment on their daytime behaviour Journal of American Academy of Child and Adolescent Psychiatry 33 1114 1121 10.1097/00004583-199410000-00007
33. A Miyamoto J Oki S Takahashi, et al. 1999 Serum melatonin kinetics and long-term melatonin treatment for sleep disorders in Rett syndrome Brain and Development 21 59 62 10.1016/S0387-7604(98)00072-2 10082254 (Pubitemid 29073347)
34. JJ Mulchahey DR Goldwater FP Zemlan 2004 A single blind placebo controlled across groups dose escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics of the melatonin analog Beta-methyl-6- chloromelatonin Life Sciences 75 1843 1856 15302228
35. National Autistic Society (2009, December 15th). Sleep and autism: Helping your child. Retrieved from http://www.nas.org.uk/nas/jsp/polopoly.jsp?d= 528&a=3376.
36. H Niederhofer, et al. 2003 Brief report: Melatonin facilitates sleep in individuals with mental retardation and insomnia Journal of Autism and Developmental Disorders 33 4 469 472 10.1023/A:1025027231938 12959427 (Pubitemid 37127944)
37. I Nir D Meir N Zilber H Knobler J Hadjez 1995 Brief report: Circadian melatonin, thyroid stimulating hormone, prolactin, and cortisol levels in serum of young adults with autism Journal of Autism and Developmental Disorders 25 641 654 10.1007/BF02178193 8720032 (Pubitemid 26006039)
38. P Norton C Drew 1994 Autism and potential family stressors The American Journal of Family Therapy 22 1 67 76 10.1080/01926189408251298
39. O'Connell A, Chapparo C (2002) The trouble with sleeping can a waterbed help? Inaugural World Autism Conference.
40. LM Patzold AL Richdale BJ Tonge 1998 An investigation into the sleep characteristics of children with autism and Asperger's disorder Journal of Paediatrics and Child Health 34 528 533 10.1046/j.1440-1754.1998.00291.x 9928644 (Pubitemid 29028690)
41. L Phillips R Appleton 2004 Systematic review of melatonin treatment in children with neurodevelopmental disabilities and sleep impairment Developmental Medicine and Child Neurology 46 11 771 775 10.1111/j.1469-8749.2004.tb00998.x 15540639
42. L Quine 1992 Severity of sleep problems in children with severe learning disabilities: Description and correlates Journal of Community and Applied Social Psychology 2 247 268 10.1002/casp.2450020404
43. L Quine 2001 Sleep problems in primary school children: Comparison between mainstream and special school children care Health and Development. 37 3 201 221 10.1046/j.1365-2214.2001.00213.x
44. P Ramachandani L Wiggs V Webb G Stores 2000 A systematic review of treatments for settling problems and night waking in young children BMJ 320 209 213 10.1136/bmj.320.7229.209 (Pubitemid 30175734)
45. AL Richdale 1999 Sleep problems in autism: Prevalence, cause and intervention Developmental Medicine and Child Neurology 41 60 66 10.1017/S0012162299000122 10068053 (Pubitemid 29027550)
46. RL Sack RJ Hughs DM Edgar AJ Lewy 1997 Sleep-promoting effects of melatonin. At what dose, in whom, under what circumstances, and by what mechanisms? Sleep 20 908 915 9415954
47. S Sheldon 1998 Pro-convulsant effects of oral melatonin in neurologically disabled children Lancet 351 1254 10.1016/S0140-6736(05)79321-1 9643754 (Pubitemid 28181974)
48. JF Simonds H Parraga 1982 Prevalence of sleep disorders and sleep behaviours in children and adolescents Journal of the American Academy of Child Psychiatry 21 383 388 10.1016/S0002-7138(09)60942-0 6981663
49. MG Smits EE Nagtegaal R Van Der Heijden, et al. 2001 Melatonin for chronic onset sleep disorder in children: A randomised placebo-controlled trial Journal of Child Neurology 16 86 92 11292231
50. MG Smits HF Van Stel R Van Der Heijden, et al. 2003 Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: A randomised placebo-controlled trial Journal of the American Academy of Child and Adolescent Psychiatry 42 1286 1293 10.1097/01.chi.0000085756.71002. 86 14566165 (Pubitemid 39585988)
51. G Stores 2003 Medication for sleep wake disorders Archives of Disease in Childhood 88 899 903 10.1136/adc.88.10.899 14500311 (Pubitemid 37194048)
52. ER Sutherland RJ Martin MC Ellison M Kraft 2002 Immunomodulatory effects of melatonin in asthma American Journal of Respiratory Critical care Medicine 166 1055 1061 10.1164/rccm.200204-356OC (Pubitemid 35178702)
53. R Tuchman I Rapin 2002 Epilepsy in autism Lancet Neurology 1 6 352 358 10.1016/S1474-4422(02)00160-6 12849396 (Pubitemid 37159160)
54. WHO (1993). The ICD-10 Classification of mental and behavioural disorders:- Diagnostic Criteria for Research: General World Health Organisation.
55. MB Wasdell JE Jan MM Bomben RD Freeman WJ Rietveld J Tai D Hamilton MD Weiss 2008 A randomised, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities Journal of Pineal Research 44 57 64 18078449
56. S Weiskop A Richdale J Matthews 2005 Behavioural treatment to reduce sleep problems in children with autism or fragile X syndrome Developmental Medicine and Child Neurology 47 94 104 10.1017/S0012162205000186 15707232 (Pubitemid 40246490)
57. L Wiggs G Stores 2001 Behavioural treatment for sleep problems in children with severe intellectual disabilities and daytime challenging behaviour: Effect on mothers and fathers British Journal of Health Psychology 6 3 257 269 10.1348/135910701169197 14596726 (Pubitemid 32906469)
58. L Wiggs G Stores 2004 Sleep patterns and sleep disorders in children with autism spectrum disorders: Insights using parent report and actigraphy Developmental Medicine and Child Neurology 46 372 380 10.1017/S0012162204000611 15174528 (Pubitemid 38696976)
59. World Health Organisation (1993). The ICD - 10 Classification of Mental and Behavioural Disorders:- Diagnostic Criteria for Research: General World Health Organisation.