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21 March 2013
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| A multidisciplinary study of the management of neuroleptic medication in schizophrenia: Educational and collaborative approaches |
| ISRCTN | ISRCTN93636537 |
| DOI | 10.1186/ISRCTN93636537 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | A multidisciplinary study of the management of neuroleptic medication in schizophrenia: Educational and collaborative approaches |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | G9322371 |
| Study hypothesis |
1. To investigate the determinants of psychotic patients' adherence to prescribed neuroleptic medication
2. To compare two different approaches to enhancing patients' adherence to prescribed neuroleptic medication |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Schizophrenia |
| Participants - inclusion criteria | Patients suffering from Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) schizophrenia or schizoaffective disorder admitted to acute psychiatric wards in the North West of England and North Wales. |
| Participants - exclusion criteria | Not provided at time of registration |
| Anticipated start date | 01/06/1995 |
| Anticipated end date | 01/06/2000 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 228 |
| Interventions |
1. Compliance intervention (patients educated about benefits of neuroleptic medication)
2. Alliance intervention (structured intervention in which patients are encouraged to rationally appraise the costs and benefits of their neuroleptic medication) 3. Treatment as usual |
| Primary outcome measure(s) |
1. Attitudes towards neuroleptic medication as measured by the Drug Attitudes Inventory
2. Psychotic symptoms as measured by the Positive and Negative Syndromes Scale |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications |
Articles directly relating to the trial itself:
1. Rogers, A., Day, J., Wood, P., Randall, F., Healy, D. and Bentall, R.P. The meaning and management of neuroleptic medication: A study of patients with a diagnosis of schizophrenia. Social Science and Medicine, 47, 1313-1323, 1998. = PMID: 9783874. 2. Rogers, A., Day, J.C., Randall, F. and Bentall, R.P. Patients' understanding and participation in a trial designed to improve the management of anti-psychotic medication: a qualitative study. International Journal of Social Psychiatry, 38, 203, 720-727, 2003. = PMID: 14689177. 3. Day, J.C., Bentall, R.P., Roberts, C., Randall, F., Rogers, A., Cattell, D., Healy, D., Wood, P., and Reid, C. Adherence with antipsychotic medication: The impact of clinical variables and relationships with health professionals. Archives of General Psychiatry, 62, 717-724, 2005 = PMID: 15997012. Papers peripheral to the main aims of the trial based on the data we collected: 1. Foster, J., Finlayson, S., Bentall, R.P., Day, J., Randall, F., Wood, P., Reid, D., Rogers, A. and Healy, D. The perceived expressed emotion in staff scale. Journal of Psychiatric and Mental Health Nursing, 10, 109-117, 2003. 2. Randall, F., Corcoran, R., Day, J. C., & Bentall, R. P. (2001). Attention, theory of mind and causal attributions in people with paranoid delusions: A preliminary investigation. Cognitive Neuropsychiatry, 8, 287-294. |
| Contact name | Professor Richard Bentall |
| Address |
Psychology Department
University of Manchester Coupland 1 Building Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| Sponsor | Medical Research Council (MRC) (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 23/10/2000 |
| Last edited | 30/07/2009 |
| Date ISRCTN assigned | 23/10/2000 |
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