Condition category
Mental and Behavioural Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Richard Bentall

ORCID ID

Contact details

Psychology Department
University of Manchester
Coupland 1 Building
Oxford Road
Manchester
M13 9PL
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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.

Publication citations

Additional files

Editorial Notes