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ISRCTN
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ISRCTN75187865
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ClinicalTrials.gov identifier
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Public title
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Cognitive remediation for young people with schizophrenia
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Scientific title
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Acronym
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N/A
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Serial number at source
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SCYP 97/06
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Study hypothesis
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Cognitive remediation will improve cognition relative to treatment as usual
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Lay summary
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Ethics approval
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Approved by the South London and Maudsley Ethics Committee as an amendment to a previous application, reference number: 008/99 and the North East London Ethics Committee Oct 02, reference number: P/02/192
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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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Schizophrenia
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Participants - inclusion criteria
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1. A diagnosis of schizophrenia according to the Diagnostic and Statistical Manual, 4th (DSM IV); had a first episode while still a teenager and their duration of illness was 3 years or less
2. Cognitive difficulties in cognitive flexibility (below the 16th centile on the Wisconsin Card Sort Test) and/or memory (poor performance on the Rivermead Behavioural Memory Test)
3. Difficulties in social functioning (at least one problem on the Social Behaviour Scale)
4. Stable medication, in terms of type and dose, for at least one month prior to inclusion
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Participants - exclusion criteria
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1. Evidence of organic brain disorder (e.g. epilepsy)
2. A diagnosis of current substance abuse as defined by the DSM IV
3. A plan to change medication during the trial
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Anticipated start date
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30/09/1998
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Anticipated end date
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30/09/2004
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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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40
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Interventions
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Cognitive remediation therapy versus usual care
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Primary outcome measure(s)
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1. Cognitive flexibility (number of categories achieved on the Wisconsin Card Sort Test [WCST] Heaton et al.)
2. Memory (raw score from Digit Span: Wechsler Adult Intelligence Scale-III [WAIS-III] Wechsler,1981)
3. Planning (modified six elements)
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Secondary outcome measure(s)
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1. Social Behaviour Schedule ([SBS] Wykes and Sturt, 1986) for social functioning
2. Brief Psychiatric Rating Scale (for symptoms) using Lukoff et al. version and Shaffer Factor Scores
3. Quality of Life Scale (for social inclusion)
4. Rosenberg Self Esteem Scale (Rosenberg, 1965)
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Sources of funding
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Mental Health Foundation SCYP 97/06, research support account PAH9009
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Trial website
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Publications
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1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17524620
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Contact name
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Prof
Til
Wykes
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Address
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Department of Psychology
P O Box 77
Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor
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King's College London (UK)
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Address
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De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Sponsor website:
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http://www.iop.kcl.ac.uk
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Date applied
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20/03/2006
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Last edited
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07/12/2010
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Date ISRCTN assigned
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05/05/2006
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