Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0146155662
Study information
Scientific title
Acronym
Study hypothesis
To identify the effects of introduction of two assessment scales to regularly appraise antipsychotic-induced side effects in forensic psychiatric patients on management of these side effects and patients' clinical outcome.
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
Two assessment scales
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Changes/differences in the scales ratings at the baseline and the end-assessment within the control and study group and between groups. Differences in the general mental health rating at the beginning and the end-assessment between the control and the study groups. Associations between side effects assessment and the general mental health status.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2003
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
30 (study) and 30 (control) patients in the Forensic Mental Health Unit, Homerton
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30 (study) and 30 (control) patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2003
Recruitment end date
30/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Homerton Hospital NHS Trust
London
E9 6SR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East London and The City Mental Health 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