Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9322371
Study information
Scientific title
Acronym
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Neuroleptics
Primary outcome measures
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 measures
Not provided at time of registration
Overall trial start date
01/06/1995
Overall trial end date
01/06/2000
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
228
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1995
Recruitment end date
01/06/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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.