Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes