The impact of routine utilization of two assessment scales on management of antipsychotic-induced side effects

ISRCTN ISRCTN88391730
DOI https://doi.org/10.1186/ISRCTN88391730
Protocol serial number N0146155662
Sponsor Department of Health
Funder East London and The City Mental Health NHS Trust (UK)
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
25/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
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

Homerton Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and Behavioural Disorders: Psychosis
InterventionTwo assessment scales
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/04/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration60
Key inclusion criteria30 (study) and 30 (control) patients in the Forensic Mental Health Unit, Homerton
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2003
Date of final enrolment30/04/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Homerton Hospital NHS Trust
London
E9 6SR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan