Neuroleptics in the treatment of aggressive challenging behaviour for people with intellectual disabilities: A randomised controlled trial (NACHBID)

Health Technology Assessment

Volumn 13, Issue 21, 2009, Pages 1-54

  Tyrer, P ^a   Oliver Africano, P ^a   Romeo, R ^b   Knapp, M ^b   Dickens, S ^a   Bouras, N ^c   Ahmed, Z ^d   Cooray, S ^e   Deb, S ^f   Murphy, D ^b   Hare, M ^d   Meade, M ^a   Reece, B ^a   Kramo, K ^a   Bhaumik, S ^g   Harley, D ^h   Regan, A ⁱ   Thomas, D ^j   Rao, B ^a   Karatela, S ^h   Lenotre L ^e   Watson, J ^g   Soni, A ^k   Crawford, M ^a   Eliahoo, J ^a   North, B ^a   more..

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c GUY S HOSPITAL   (United Kingdom)

^d CARDIFF UNIVERSITY   (United Kingdom)

^e CENTRAL AND NORTH WEST LONDON NHS FOUNDATION TRUST   (United Kingdom)

^f UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^g LEICESTERSHIRE PARTNERSHIP NHS TRUST   (United Kingdom)

^h UNIVERSITY OF QUEENSLAND   (Australia)

ⁱ Orme Lodge   (United Kingdom)

^j NORTH EAST LONDON NHS FOUNDATION TRUST   (United Kingdom)

^k WEST LONDON MENTAL HEALTH NHS TRUST   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HALOPERIDOL; LORAZEPAM; OLANZAPINE; PLACEBO; RISPERIDONE; NEUROLEPTIC AGENT;

ADULT; AGED; AGGRESSION; ANXIETY DISORDER; ARTICLE; AUSTRALIA; AUTISM; BEHAVIOR DISORDER; BEHAVIOR THERAPY; CHECKLIST; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL PRACTICE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; CROSSOVER PROCEDURE; DEPRESSION; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG COST; DRUG DOSE INCREASE; DRUG EFFECT; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ECONOMIC ASPECT; ETHICS; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HEALTH CARE COST; HEALTH CARE PLANNING; HEALTH SERVICE; HOSPITAL CARE; HOSPITALIZATION; HUMAN; INFORMED CONSENT; INTELLECTUAL IMPAIRMENT; LEARNING DISORDER; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MANIA; MULTICENTER STUDY; OCCUPATIONAL THERAPY; OUTCOME ASSESSMENT; PRESCRIPTION; PSYCHOSIS; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCHIZOPHRENIA; SIDE EFFECT; SPEECH THERAPY; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; UNITED KINGDOM; WEIGHT GAIN; ADOLESCENT; DOSE RESPONSE; MENTAL PATIENT; MIDDLE AGED; PSYCHOLOGICAL ASPECT;

ADOLESCENT; ADULT; AGED; AGGRESSION; ANTIPSYCHOTIC AGENTS; COST-BENEFIT ANALYSIS; DOSE-RESPONSE RELATIONSHIP, DRUG; ENGLAND; FEMALE; HALOPERIDOL; HUMANS; MALE; MENTALLY DISABLED PERSONS; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PLACEBOS; RISPERIDONE; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 67650388358     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta13210     Document Type: Article

References (74)

1. Emerson E, McGill P, Mansell J. Severe learning disabilities and challenging behaviours - designing high quality services. London: Chapman and Hall; 1994.
2. Smith S, Branford D, Collacott RA, Cooper SA, McGrother C. Prevalence and cluster typology of maladaptive behaviors in a geographically defined population of adults with learning disabilities. Br J Psychiatry 1996;169:219-227 (Pubitemid 126735166)
3. Brylewski J, Duggan L. Neuroleptic medication for challenging behaviour in people with intellectual disability: a systematic review of randomised controlled trials. J Intellect Disabil Res 1994;43:360-71.
4. Emerson E, McGill P, Mansell J. Severe learning disabilities and challenging behaviours - designing high quality services. London: Chapman and Hall; 1994.
5. Brylewski J, Duggan L. Neuroleptic medication for challenging behaviour in people with intellectual disability: a systematic review of randomised controlled trials. J Intellect Disabil Res 1999;43:360-71.
6. Casey JF, Lasky JJ, Klett CJ, Hollister LE. Treatment of schizophrenic reactions with phenothiazine derivatives. Am J Psychiatry 1960;117:97-105.
7. Bair HV, Herold W. Efficacy of chlorpromazine in hyperactive mentally retarded children. Arch Neurol Psychiatry 1955;74:363-364
8. Linaker OM. Frequency and determinants for psychotropic drug use in an institution for the mentally retarded. Br J Psychiatry 1990;156:525-530 (Pubitemid 20116599)
9. Clarke DJ, Kelley S, Thinn K, Corbett JA. Psychotropic drugs and mental retardation: disabilities and the prescription of drugs for behaviour and for epilepsy in three residential settings. J Ment Deficiency Res 1990;34:385-395 (Pubitemid 20357841)
10. Branford D. A study of the prescribing for people with learning disabilities living in the community and in National Health Service care. J Intellect Disabil Res 1994;38:577-586
11. Cooper S-A, Smiley E, Morrison J, Williamson A, Allan L. Mental ill-health in adults with intellectual disabilities: prevalence and associated factors. Br J Psychiatry 2007;190:27-35. (Pubitemid 46121498)
12. McGrother CW, Byrne V, Thorp G, Tyrer F, Watson J. Leicestershire learning disability register: annual report for the Department of Health. Leicester: University of Leicester; 2006.
13. Kiernan C, Reeves D, Alborz A. The use of neuroleptic drugs with adults with learning disabilities and challenging behaviour. J Intellect Disabil Res 1995;39:263-274
14. British Medical Association and Royal Pharmaceutical Society of Great Britain. British national formulary 51 (March). London: BMA, RPS; 2006.
15. National Institute for Clinical Excellence. Clinical guideline 1. Schizophrenia: core interventions in the treatment and management of schizophrenia in primary and secondary care. London: NICE; 2002.
16. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of neuroleptic drugs in patients with chronic schizophrenia. New Eng J Med 2005;353:1209-1223 (Pubitemid 41345943)
17. Jones PB, Barnes TR, Davies L, Dunn G, Lloyd H, Hayhurst KP, et al. Randomized controlled trial of the effect on quality of life of second- vs first-generation neuroleptic drugs in schizophrenia: cost utility of the latest neuroleptic drugs in schizophrenia study (CUtLASS 1). Arch Gen Psychiatry 2006;63:1079-1087 (Pubitemid 44498387)
18. Davies LM, Lewis S, Jones PB, Barnes TRE, Gaughran F, Hayhurst K, et al. on behalf of the CUtLASS team. Cost-effectiveness of first- v. second- generation antipsychotic drugs: results from a randomised controlled trial in schizophrenia responding poorly to previous therapy. Br J Psychiatry 2007;191:14-22.
19. Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multicentre, double-blind, parallel-group study versus haloperidol. Br J Psychiatry 1995;166:712-726
20. Lou R.S, Kerrick JM, Cohen SA. Clinical and economic aspects of risperidone treatment in adults with mental retardation and behavioural disturbance. Psychopharmacol Bull 1996;32:721-729
21. Van den Borre R, Vermote R, Buttiens M, Thiry P, Dierick G, Geutjens J, et al. Risperidone as an add-on therapy in behavioural disturbances in mental retardation: a double-blind placebo-controlled cross-over study. Acta Psychiatr Scand 1993;87:167-71. (Pubitemid 23079926)
22. Netten, A, Rees, T, Harrison, G. Unit costs of health and social care 2000. Canterbury: PSSRU; 2001.
23. Ahmed Z, Fraser W, Kerr MP, Kiernan C, Emerson E, et al. Reducing neuroleptic medication in people with a learning disability. Br J Psychiatry 2000;176:2-6. (Pubitemid 30051087)
24. Hermann L, Lanctot KL. Do atypical neuroleptics cause stroke? CNS drugs 2005;19:91-103.
25. Glick H, Doshi J, Sonnad S, Polsky D. Economic evaluation in clinical trials. Oxford: Oxford University Press; 2007.
26. Drummond M, O'Brien B, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. 3rd edn. Oxford: Oxford University Press; 2007.
27. Curtis L, Netten A. Unit costs of health and social care 2006. Canterbury: PSSRU; 2006.
28. Department of Health. National Health Service schedule of reference costs 2006. URL: www.doh.gov.uk/nhsexec/refcosts.htm. Accessed February 2007.
29. Incomes Data Services. The national minimum wage October 2005. URL: www.incomesdata.co.uk/information/minwage.htm. Accessed February 2007.
30. Rothman, DJ, Rothman SM. The Willowbrook wars. New York: Harper & Row; 1984.
31. Fraser WI. Three decades after Penrose. Br J Psychiatry 2000;176:10-11.
32. Medical Research Council. The ethical conduct of research on the mentally incapacitated. MRC Ethics Series: Working Party on Research of the Mentally Incapacitated. UK: London; December 1991. Reprinted August 1993.
33. Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Deficiency 1985;89:485-491
34. Altman DG. Practical statistics for medical research. London: Chapman Hall; 1991.
35. Al M, Van Hout B, Michel B, Rutten F. Sample size calculations in economic evaluations. Health Econ 1998;7:327-335 (Pubitemid 28339961)
36. Briggs A. Economic evaluation and clinical trials: size matters. BMJ 2000;321:1362-1363
37. Schalock RL, Keith KD. Quality of life questionnaire. Ohio: IDS Publishing Corporation; 1993.
38. Pruchno R. The effects of help patterns on the mental health of spouse caregivers. Res Ageing 1990;12:57-71. (Pubitemid 20299771)
39. Guy W, editor. ECDEU assessment manual for psychopharmacology. DHEW Public No. ADM-76-338. Washington DC: Government Printing Office; 1976.
40. McCracken JT, McGough J, Shah B, et al. Risperidone in children with autism and serious behavioural problems. New Eng J Med 2002;347:314-320 (Pubitemid 34815353)
41. Silver JM, Yudofsky SC. The overt aggression scale: overview and guiding principles. J Neuropsychiatry 1991;3:522-529
42. Yudofsky SC, Silver JM, Jackson W, Endicott J, Williams D. The overt aggression scale for the objective rating of verbal and physical aggression. Am J Psychiatry 1986;143:35-39 (Pubitemid 16185859)
43. Sorgi P, Ratey J, Knoedler DW, Market RJ, Reichman M. Rating aggression in the clinical setting - a retrospective adaptation of the overt aggression scale: preliminary results. J Neuropsychiatry 1991;3:552-556
44. Kho K, Sensky T, Mortimer A, Corcos C. Prospective study into factors associated with aggressive incidents in psychiatric acute admission wards. Br J Psychiatry 1998;172:38-43. (Pubitemid 28122525)
45. Ratey JJ, Gutheil CM. The measurement of aggressive behaviour: reflections on the use of the overt aggression scale and the modified overt aggression scale. J Neuropsychiatry 1991;3:557-560
46. Oliver PC, Crawford MJ, Rao B, Reece B, Tyrer P. Modified overt aggression scale (MOAS) for people with intellectual disability and aggressive challenging behaviour: a reliability study. J Appl Res Intellect Disabil 2007;20:368-372
47. Marshburn EC, Aman MG. Factor validity and norms for the aberrant behavior checklist in a community sample of children with mental retardation, J Autism Devel Disord 1992;22:357-373
48. Prosser H, Moss SC, Costello H, Simpson N, Patel P, Rowe S, et al. Reliability and validity of the mini PAS-ADD for assessing psychiatric disorders in adults with intellectual disability. J Intellect Disabil Res 1998;42:264-272 (Pubitemid 28403226)
49. Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K. The UKU side effect rating scale: a new comprehensive rating scale for psychotropic drugs, and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand 1987;334(Suppl.):1-100. (Pubitemid 17115352)
50. Byford S, Leese M, Knapp M, Seivewright H, Cameron S, Jones V, et al. Comparison of alternative methods of collection of service use data for the economic evaluation of health care interventions. Health Econ 2007;16:531-536 (Pubitemid 46784286)
51. Patel A, Rendu A, Moran P, Leese M, Mann A, Knapp M. A comparison of two methods of collecting economic data in primary care. Fam Pract 2005;22:323-327 (Pubitemid 40744513)
52. Romeo R, Patel A, Knapp M, Thomas C. The cost-elfectiveness of mirtazapine versus paroxetine in treating people with depression in primary care. Int Clin Pychopharmacol 2004;19:125-134 (Pubitemid 38586483)
53. Tyrer P, Oliver-Africano PC, Ahmed Z, Bouras N, Cooray S, Deb S, et al. Risperidone, haloperidol and placebo in the treatment of aggressive challenging behaviour in intellectual disability: randomised controlled trial. Lancet 2008;371:55-61.
54. Campbell MK, Snowdon C, Francis D, Elbourne AM, McDonald R, Knight V, et al. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess 2007;11(48).
55. Garcia DJ, Roberts I, Grant A. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess 2007;11(48).
56. Geddes J, Goodwin G. Bipolar disorder: clinical uncertainty, evidence-based medicine and large-scale randomised trials. Br J Psychiatry 2001;178(Suppl. 41):191-194 (Pubitemid 32530350)
57. Campbell M, Fitzpatrick R, Haines A, Kinmouth, AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321:694-696
58. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials - literature summary and annotated bibliography. J Clin Epidemiol 1999;52:1143-1156
59. EN Directive 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. Off J Europ Commun 2001;L121/34-L121/44.
60. Le Surf M. No grounds for testing. Commun Care 2003, 10 July.
61. Tyrer P, Cooray S. Put knowledge before ignorance. Community Care 2004; 15 July.
62. Oliver PC, Piachaud J, Done J, Regan A, Cooray S, Tyrer P. Difficulties in conducting a randomised controlled trial of health service interventions in intellectual disability: implications for evidence-based practice. J Intellect Disabil Res 2002;46:340-345 (Pubitemid 34567666)
63. Tungaraza T, Poole R. Influence of drug company authorship and sponsorship on drug trial outcomes. Br J Psychiatry 2000;191:82-83
64. Ukoumunne OC. A comparison of confidence interval methods for the intraclass correlation coefficient in cluster randomized trials. Stat Med 2002;21:3757-3774
65. Scahill L, McCracken J, McDougle CJ, Aman M, Arnold LE, Tierney E, et al. Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism. J Clin Psychopharmacol 2001;11:377-388
66. Gagiano C, Read S, Thorpe L, Eerdekens M, Van Hove I. Short and long-term efficacy and safety of risperidone in adults with disruptive behavior disorders. Psychopharmacology (Berl) 2005;179:629-36. (Pubitemid 40674764)
67. Haessler F, Glaser T, Beneke LJ, Pap AF, Bodenschatz R, Reis O, et al. Zuclopenthixol in aggressive challenging behaviour in learning disability: discontinuation study. Br J Psychiatry 2007;190:447-448
68. Deb S, Clarke D, Unwin G. Using medication to manage behaviour problems among adults with a learning disability: quick reference guide. Birmingham: University of Birmingham; 2006.
69. Janowsky DS, Kraus JE, Barnhill LJ, Elamir B, Davis JM. Effects of topiramate on aggressive, self-injurious, and disruptive/destructive behaviors in the intellectually disabled: an open-label retrospective study. J Clin Psychopharmacol 2003;23:500-501 (Pubitemid 37138635)
70. Taylor JL, Novaco RW, Gillmer B, Thorne I. Cognitive-behavioural treatment of anger intensity among offenders with intellectual disabilities. J Appl Res Intellect Disabil 2002;15:151-165 (Pubitemid 36725536)
71. Willner P. The effectiveness of psychotherapeutic interventions for people with learning disabilities: a critical overview. J Intellect Disabil Res 2005;49:73-85. (Pubitemid 40246475)
72. Haddock K, Jones RS. Practitioner consensus in the use of cognitive behaviour therapy for individuals with a learning disability. J Intellect Disabil Res 2006;10:221-230
73. Tyrer P, Sensky T, Mitchard S. The principles of nidotherapy in the treatment of persistent mental and personality disorders. Psychother Psychosom 2003;72:350-356 (Pubitemid 37266912)
74. Tyrer P, Kranio K. Niclotherapy in practice. J Ment Health 2007;16:117-131