Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9519373
Study information
Scientific title
Acronym
SOCRATES
Study hypothesis
To evaluate the effectiveness of cognitive behaviour therapy in parallel with drug treatments as usual in early acute schizophrenia. The hypothesis is that CBT is an acceptable adjunct to drug treatment which will accelerate resolution of target psychotic symptoms and reduce relapse.
Ethics approval
Not provided at time of registration
Study design
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
Neurosciences, psychiatry
Intervention
Cognitive behaviour therapy/drug treatments
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Change on core symptom scores on hallucination and delusion rating scales
2. Change in total symptoms scores on PANSS
3. Time to criterion of 50% recovery operationally defined -
4. Number of days in hospital before 1st discharge and during follow-up
5. Time to relapse
6. Follow-up symptom and outcome scores at 3.9 and 18 months
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1996
Overall trial end date
31/03/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive sample of in- or day-patients admitted with 1st and 2nd episode schizophrenia aged 18-65. Further inclusion criteria:
1. Able to give informed consent
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition (DSMIV) diagnostic criteria for schizophrenia, schizophreniform or schizoaffective disorder with at least a 1 month history of positive symptoms
3. No significant history of organic brain disease or substance misuses for major aetiological factor for psychosis
4. Positive and negative syndrome scale (PANSS) for schizophrenia score of at least 4 on item hallucinatory behaviour and/or item delusions
5. Score of less than 5 on PANSS item conceptual disorganisation
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
236
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1996
Recruitment end date
31/03/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychiatry and Behavioural Science
Manchester
M20 8LR
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Lewis, S., Tarrier, N., Haddock, G., et al (2002) Randomised, controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes. British Journal of Psychiatry, 181 (suppl. 43), s91-s97