Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.