Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used

Article

Pope, A., Adams, C., Paton, C., Weaver, T. and Barnes, T.R.E. 2010. Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used. The British Journal of Psychiatry. 197 (1), pp. 67-72. https://doi.org/10.1192/bjp.bp.109.070961
TypeArticle
TitleAssessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used
AuthorsPope, A., Adams, C., Paton, C., Weaver, T. and Barnes, T.R.E.
Abstract

Background: Clinical studies of antipsychotic medication are a primary source of data on the nature of, and relative liability for, adverse effects, relevant to prescribing decisions in clinical practice.
Aims: To identify how safety and tolerability data were collected and reported in recent clinical studies of antipsychotics.
Method: A survey was conducted of all 167 eligible studies published between 2002 and 2007 on the Cochrane Schizophrenia Group register.
Results: Extrapyramidal side-effects (EPS) and weight gain were most frequently assessed. A minority of reports addressed metabolic abnormalities, aversive subjective experiences and sexual dysfunction. Published rating scales were frequently used to evaluate EPS, but systematic methods were rarely applied to other treatment-emergent problems. The definition of individual adverse effects and the manner of reporting were inconsistent.
Conclusions: The way in which safety and tolerability data are collected and reported in clinical studies does not allow for fair and meaningful comparison of the relative risk profiles of individual antipsychotic drugs.

PublisherCambridge University Press (CUP)
Royal College of Psychiatrists
JournalThe British Journal of Psychiatry
ISSN0007-1250
Electronic1472-1465
Publication dates
PrintJul 2010
Publication process dates
Deposited02 Dec 2019
Accepted20 Apr 2010
Output statusPublished
Digital Object Identifier (DOI)https://doi.org/10.1192/bjp.bp.109.070961
Web of Science identifierWOS:000279596900014
LanguageEnglish
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The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams
Newton-Howes, G., Tyrer, P., Anagnostakis, K., Cooper, S., Bowden-Jones, O. and Weaver, T. 2010. The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams. Social Psychiatry and Psychiatric Epidemiology. 45 (4), pp. 453-460. https://doi.org/10.1007/s00127-009-0084-7
A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders
Charles, V. and Weaver, T. 2010. A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders. Journal of Mental Health. 19 (1), pp. 99-106. https://doi.org/10.3109/09638230802523039
Child involvement in the paediatric consultation: a qualitative study of children and carers' views
Taylor, S., Haase-Casanovas, S., Weaver, T., Kidd, J. and Garralda, E.M. 2010. Child involvement in the paediatric consultation: a qualitative study of children and carers' views. Child: Care, Health & Development. 36 (5), pp. 678-685. https://doi.org/10.1111/j.1365-2214.2010.01076.x
Delusions and qualitative confusions: a dialogic collaborative exploration
Patterson, S., Hart, J. and Weaver, T. 2010. Delusions and qualitative confusions: a dialogic collaborative exploration. Qualitative Health Research. 20 (7), pp. 1008-1018. https://doi.org/10.1177/1049732310363805
User involvement in efforts to improve the quality of drug misuse services in England: a national survey
Patterson, S., Weaver, T., Agath, K., Rutter, D., Albert, E. and Crawford, M. 2009. User involvement in efforts to improve the quality of drug misuse services in England: a national survey. Drugs: Education, Prevention, and Policy. 16 (4), pp. 364-377. https://doi.org/10.1080/09687630802061544
Dedicated personality disorder services: a qualitative analysis of service structure and treatment process
Price, K., Gillespie, S., Rutter, D., Dhillon, K., Gibson, S., Faulkner, A., Weaver, T. and Crawford, M.J. 2009. Dedicated personality disorder services: a qualitative analysis of service structure and treatment process. Journal of Mental Health. 18 (6), pp. 467-475. https://doi.org/10.3109/09638230902968191
'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England
Patterson, S., Weaver, T., Agath, K., Albert, E., Rhodes, T., Rutter, D. and Crawford, M. 2009. 'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England. Health and Social Care in the Community. 17 (1), pp. 54-62. https://doi.org/10.1111/j.1365-2524.2008.00797.x
Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London
Singh, S., Paul, M., Ford, T., Kramer, T. and Weaver, T. 2008. Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London. BMC Health Services Research. 8 (1), pp. 1-7. https://doi.org/10.1186/1472-6963-8-135
Attitudes of staff towards patients with personality disorder in community mental health teams
Newton-Howes, G., Weaver, T. and Tyrer, P. 2008. Attitudes of staff towards patients with personality disorder in community mental health teams. Australian & New Zealand Journal of Psychiatry. 42 (7), pp. 572-577. https://doi.org/10.1080/00048670802119739
Social functioning of patients with personality disorder in secondary care
Newton-Howes, G., Tyrer, P. and Weaver, T. 2008. Social functioning of patients with personality disorder in secondary care. Psychiatric Services. 59 (9), pp. 1033-1037. https://doi.org/10.1176/ps.2008.59.9.1033
Dedicated community-based services for adults with personality disorder: Delphi study
Crawford, M.J., Price, K., Rutter, D., Moran, P., Tyrer, P., Bateman, A., Fonagy, P. and Weaver, T. 2008. Dedicated community-based services for adults with personality disorder: Delphi study. The British Journal of Psychiatry. 193 (4), pp. 342-343. https://doi.org/10.1192/bjp.bp.107.043042
Qualitative investigation of the mental health of migrants from former Yugoslavia: implications for epidemiological research
Djuretic, T., Crawford, M. and Weaver, T. 2007. Qualitative investigation of the mental health of migrants from former Yugoslavia: implications for epidemiological research. Journal of Mental Health. 16 (6), pp. 743-755. https://doi.org/10.1080/09638230701496394
Prevalence of personality disorder in alcohol and drug services and associated comorbidity
Bowden-Jones, O., Iqbal, M., Tyrer, P., Seivewright, N., Cooper, S., Judd, A., Weaver, T. and the COSMIC study team 2004. Prevalence of personality disorder in alcohol and drug services and associated comorbidity. Addiction. 99 (10), pp. 1306-1314. https://doi.org/10.1111/j.1360-0443.2004.00813.x
User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers
Crawford, M.J., Aldridge, T., Bhui, K., Rutter, D., Manley, C., Weaver, T., Tyrer, P. and Fulop, N. 2003. User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers. Acta Psychiatrica Scandinavica. 107 (6), pp. 410-414. https://doi.org/10.1034/j.1600-0447.2003.00049.x
Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial
Weaver, T., Tyrer, P., Ritchie, J. and Renton, A. 2003. Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial. The British Journal of Psychiatry. 183 (5), pp. 437-435. https://doi.org/10.1192/bjp.183.5.437
Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough
Weaver, T., Rutter, D., Madden, P., Ward, J., Stimson, G. and Renton, A. 2001. Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough. Social Psychiatry and Psychiatric Epidemiology. 36 (8), pp. 399-406. https://doi.org/10.1007/s001270170030
The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations
Weaver, T., Hickman, M., Rutter, D., Ward, J., Stimson, G. and Renton, A. 2001. The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations. Drug and Alcohol Review. 20 (4), pp. 407-416. https://doi.org/10.1080/09595230120092724
Residents' perceptions of water quality improvements following remediation work in the Pymme's Brook catchment, north London, UK
Faulkner, H., Green, A., Pellaumail, K. and Weaver, T. 2001. Residents' perceptions of water quality improvements following remediation work in the Pymme's Brook catchment, north London, UK. Journal of Environmental Management. 62 (3), pp. 239-254. https://doi.org/10.1006/jema.2001.0435
The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation
Weaver, T., Taylor, F., Cunningham, B. and Maden, A. 1997. The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation. The British Journal of Psychiatry. 170 (5), pp. 462-466. https://doi.org/10.1192/bjp.170.5.462