Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://web1.iop.kcl.ac.uk/Extras/Cutlass/index.html

Contact information

Type

Scientific

Primary contact

Prof Shon Lewis

ORCID ID

Contact details

Department of Psychiatry
University of Manchester
2nd Floor Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5888
shon.Lewis@Man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/19/06

Study information

Scientific title

Acronym

CUtLASS

Study hypothesis

Antipsychotic (neuroleptic) drugs remain central to the treatment of the symptoms of schizophrenia. Conventional drugs are effective in 70% of patients but have frequent neurological side effects. The atypical antipsychotics are a new class of drugs with a lower risk of these side effects and, in the case of clozapine, better efficacy. The cost of these new drugs is 20-30 times that of conventional drugs. There are currently no reliable data about their comparative effectiveness and cost-effectiveness in NHS settings in which to guide practice. If their use continues to expand, the annual drugs budget for schizophrenia in England will increase from £32 million to £240 million. A 4-centre, prospective, randomised, controlled trial is proposed, to evaluate the relative effectiveness of the new drugs compared to conventional drugs and to clozapine in a sample of 702 people with schizophrenia who are resistant to or intolerant of usual treatment. The trial will aim to demonstrate important differences in quality of life and other outcomes at 1 year, assess value for money and identify cost-effective management strategies.

Ethics approval

Not provided at time of registration

Study design

A 4-centre, prospective, 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: Schizophrenia and other psychoses

Intervention

Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 March 1999 and 28 February 2002 to 1 May 1999 and 30 June 2003, respectively.

Interventions:
1. New drugs
2. Conventional drugs

Intervention type

Drug

Phase

Not Specified

Drug names

antipsychotics

Primary outcome measures

Quality of life

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/05/1999

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Schizophrenics who are intolerant or resistant to usual treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

227

Participant exclusion criteria

1. Substance use or organic illness as the main cause of psychotic symptoms.
2. History of neuroleptic malignant syndrome (NMS)

Recruitment start date

01/05/1999

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychiatry
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16707074

Publication citations

  1. HTA monograph

    Lewis SW, Davies L, Jones PB, Barnes TR, Murray RM, Kerwin R, Taylor D, Hayhurst KP, Markwick A, Lloyd H, Dunn G, Randomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of, current drug treatment., Health Technol Assess, 2006, 10, 17, iii-iv, ix-xi, 1-165.

Additional files

Editorial Notes