How does the regular standardized assessment of antipsychotic-induced side effects in forensic psychiatric patients affect the management of these side effects?

ISRCTN ISRCTN20829222
DOI https://doi.org/10.1186/ISRCTN20829222
Secondary identifying numbers N0024108481
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
22/08/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Albert Ngan
Scientific

Pharmacy Department
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone +44 020 8510 7252
Email albert.ngan@homerton.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo identify the effect of the introduction of two assessment scales to regularly appraise antipsychotic-induced side effects in forensic psychiatric patients on management of these side effects.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and Behavioural Disorders: Psychosis
Intervention1. Self-rating Anxiety Scale (SAS) & Brief Agitation Rating Scale (BARS) assessment + ongoing reassessments
2. Standard care
Intervention typeOther
Primary outcome measureChanges/differences in the SAS and BARS rating at the baseline and the end-assessment within the control and the study group and between the groups. Differences in the general mental health rating at the beginning and the end-assessment between the control and the study groups. Association between SAS + BARS assessment and the general mental health status.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2003
Completion date31/10/2003
Reason abandoned (if study stopped)Lack of staff

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteria30 + 30 patients, Forensic Mental Health Unit.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2003
Date of final enrolment31/10/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Pharmacy Department
London
E9 6SR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Homerton University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan