Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0172139155
Study information
Scientific title
Acronym
Study hypothesis
Does the use of the LUNSERs increase the reporting of side-effects of psychotropic medication?
Ethics approval
Not provided at time of registration
Study design
Randomised Controlled Trial (Prospective)
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
Intervention
The trial arms are self-reporting and physician questioning of side-effects versus usual care and administration of the LUNSERS scale to identify side-effects.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Use of LUNSERs, side-effects reported.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/02/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
30 clients in each arm of the trial.
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
22/02/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Psychiatry
Nottingham
NG3 6AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Nottinghamshire Healthcare 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