Cost utility of the latest antipsychotics in severe schizophrenia (CUtLASS): a multi-centre, randomised, controlled trial

ISRCTN	ISRCTN33419176
DOI	https://doi.org/10.1186/ISRCTN33419176
Secondary identifying numbers	HTA 96/19/06

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

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

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Shon Lewis
Scientific

Department of Psychiatry
University of Manchester
2nd Floor Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 5888
Email	shon.Lewis@Man.ac.uk

Study information

Study design	A 4-centre, prospective, randomised, controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Cost utility of the latest antipsychotics in severe schizophrenia (CUtLASS): a multi-centre, randomised, controlled trial
Study acronym	CUtLASS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	antipsychotics
Primary outcome measure	Quality of life
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/05/1999
Completion date	30/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	227
Key inclusion criteria	Schizophrenics who are intolerant or resistant to usual treatment
Key exclusion criteria	1. Substance use or organic illness as the main cause of psychotic symptoms. 2. History of neuroleptic malignant syndrome (NMS)
Date of first enrolment	01/05/1999
Date of final enrolment	30/06/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Psychiatry

Manchester
M23 9LT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/05/2006		Yes	No

Editorial Notes

08/11/2022: Internal review.