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ISRCTN
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ISRCTN65818527
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DOI
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10.1186/ISRCTN65818527
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Study Of Cognitive ReAlignment Therapy in Early Schizophrenia
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Scientific title
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Acronym
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SOCRATES
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Serial number at source
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G9519373
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Neurosciences, psychiatry
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1996
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Anticipated end date
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31/03/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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236
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Interventions
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Cognitive behaviour therapy/drug treatments
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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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
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Contact name
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Professor
SW
Lewis
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Address
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School of Psychiatry and Behavioural Science
University of Manchester
Withington Hospital
West Didsbury
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City/town
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Manchester
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Zip/Postcode
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M20 8LR
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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23/09/2009
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Date ISRCTN assigned
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23/10/2000
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