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 |
| Protocol serial number | N0024108481 |
| Sponsor | Department of Health (UK) |
| Funder | Homerton University Hospital NHS Trust (UK) |
- 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
Scientific
Pharmacy Department
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
| Phone | +44 020 8510 7252 |
|---|---|
| albert.ngan@homerton.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2003 |
| Reason abandoned (if study stopped) | Lack of staff |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Pharmacy Department
London
E9 6SR
United Kingdom
E9 6SR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
