Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rashi Negi

ORCID ID

Contact details

Division of Psychiatry
University of Nottingham
Duncan Macmillan House
Porcester Road
Mapperley
Nottingham
NG3 6AA
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes