Contact information
Type
Scientific
Primary contact
Mr Albert Ngan
ORCID ID
Contact details
Pharmacy Department
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 020 8510 7252
albert.ngan@homerton.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0024108481
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2003
Overall trial end date
31/10/2003
Reason abandoned
Lack of staff
Eligibility
Participant inclusion criteria
30 + 30 patients, Forensic Mental Health Unit.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2003
Recruitment end date
31/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Pharmacy Department
London
E9 6SR
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Homerton University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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