A multidisciplinary study of the management of neuroleptic medication in schizophrenia: Educational and collaborative approaches

ISRCTN	ISRCTN93636537
DOI	https://doi.org/10.1186/ISRCTN93636537
Secondary identifying numbers	G9322371

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Richard Bentall
Scientific

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

Email	abc@email.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A multidisciplinary study of the management of neuroleptic medication in schizophrenia: Educational and collaborative approaches
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Neuroleptics
Primary outcome measure	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 study start date	01/06/1995
Completion date	01/06/2000

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	228
Total final enrolment	228
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1995
Date of final enrolment	01/06/2000

Psychology Department

Manchester
M13 9PL
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/1998		Yes	No
Results article	results	01/02/2003		Yes	No
Results article	results	01/11/2003		Yes	No
Results article	results	01/12/2003		Yes	No
Results article	results	01/07/2005		Yes	No
Results article	results	01/07/2005	19/02/2020	Yes	No

19/02/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.