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

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

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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To 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) studied	Mental and Behavioural Disorders: Psychosis
Intervention	1. Self-rating Anxiety Scale (SAS) & Brief Agitation Rating Scale (BARS) assessment + ongoing reassessments 2. Standard care
Intervention type	Other
Primary outcome measure	Changes/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 measures	Not provided at time of registration
Overall study start date	01/04/2003
Completion date	31/10/2003
Reason abandoned (if study stopped)	Lack of staff

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	30 + 30 patients, Forensic Mental Health Unit.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2003
Date of final enrolment	31/10/2003

Pharmacy Department

London
E9 6SR
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Homerton University Hospital NHS Trust (UK)

No information available

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