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

ISRCTN ISRCTN93636537
DOI https://doi.org/10.1186/ISRCTN93636537
Protocol serial number G9322371
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
19/02/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Bentall
Scientific

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

Email abc@email.com

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA multidisciplinary study of the management of neuroleptic medication in schizophrenia: Educational and collaborative approaches
Study objectives1. 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) studiedSchizophrenia
Intervention1. 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Neuroleptics
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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/2000

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration228
Total final enrolment228
Key inclusion criteriaPatients 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 criteriaNot provided at time of registration
Date of first enrolment01/06/1995
Date of final enrolment01/06/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Psychology Department
Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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