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. 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.
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
JournalThe British Journal of Psychiatry
ISSN0007-1250
Electronic1472-1465
Publication dates
Print31 Jul 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
LanguageEnglish
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An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence
Rafia, R., Dodd, P., Brennan, A., Meier, P., Hope, V., Ncube, F., Byford, S., Tie, H., Metrebian, N., Hellier, J., Weaver, T. and Strang, J. 2016. An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence. Addiction. 111 (9), pp. 1616-1627. https://doi.org/10.1111/add.13385
Hearing voices simulation: Process and outcomes of training
Patterson, S., Goulter, N. and Weaver, T. 2014. Hearing voices simulation: Process and outcomes of training. Journal of Mental Health Training, Education and Practice. 9 (1), pp. 46-58. https://doi.org/10.1108/JMHTEP-01-2013-0003
Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial
Weaver, T., Metrebian, N., Hellier, J., Pilling, S., Charles, V., Little, N., Poovendran, D., Mitcheson, L., Ryan, F., Bowden-Jones, O., Dunn, J., Glasper, A., Finch, E. and Strang, J. 2014. Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial. The Lancet. 384 (9938), pp. 153-163. https://doi.org/10.1016/S0140-6736(14)60196-3
Activity and views of service users involved in mental health research: UK survey
Patterson, S., Trite, J. and Weaver, T. 2014. Activity and views of service users involved in mental health research: UK survey. The British Journal of Psychiatry. 205 (1), pp. 68-75. https://doi.org/10.1192/bjp.bp.113.128637
Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network
Borschmann, R., Patterson, S., Poovendran, D., Wilson, D. and Weaver, T. 2014. Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network. BMC Medical Research Methodology. 14 (1), p. 23. https://doi.org/10.1186/1471-2288-14-23
Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention
Wilson, E., Randall, C., Patterson, S., Emmerson, B., Moudgil, V. and Weaver, T. 2014. Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention. Australasian Psychiatry. 22 (3), pp. 248-253. https://doi.org/10.1177/1039856214529000
The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services
Belling, R., McLaren, S., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2014. The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services. Journal of Health Services Research & Policy. 19 (3), pp. 169-176. https://doi.org/10.1177/1355819614527439
Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2010. Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD). Personality Disorder Team.
Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales
Trebilcock, J. and Weaver, T. 2012. Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales. International Journal of Criminology and Sociology. 1, pp. 141-150. https://doi.org/10.6000/1929-4409.2012.01.14
‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services
McLaren, S., Belling, R., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2013. ‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services. BMC Health Services Research. 13. https://doi.org/10.1186/1472-6963-13-254
The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey
Cargill, T., Weaver, T. and Patterson, S. 2012. The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey. Drugs: Education, Prevention, and Policy. 19 (2), pp. 163-170. https://doi.org/10.3109/09687637.2011.609204
Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners
Trebilcock, J. and Weaver, T. 2012. Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners. The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 237-243. https://doi.org/10.1080/14789949.2012.668212
‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2012. ‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD). The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 244-260. https://doi.org/10.1080/14789949.2012.668208
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
Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study
Singh, S., Paul, M., Ford, T., Kramer, T., Weaver, T., McLaren, S., Hovish, K., Islam, Z., Belling, R. and White, S. 2010. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. The British Journal of Psychiatry. 197 (4), pp. 305-312. https://doi.org/10.1192/bjp.bp.109.075135
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