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ISRCTN
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ISRCTN35852420
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ClinicalTrials.gov identifier
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Public title
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Neural correlates of response to COGnitive behaviour therapy in SCHIZophrenia: a functional magnetic resonance imaging investigation
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Scientific title
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Acronym
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COGSCHIZ
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Serial number at source
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067427
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Study hypothesis
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1. Does successful treatment of symptoms of schizophrenia produce measurable changes at the brain level?
2. Are there brain predictors of the clinical response to cognitive behaviour therapy in schizophrenia?
Please note that as of 19/01/2007 the anticipated end date of this trial has now been shortened to 30/03/2007. The initial anticipated end date of your trial was 30/06/2007.
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Lay summary
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Not provided at time of registration
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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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Schizophrenia
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Participants - inclusion criteria
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Patients with a diagnosis of schizophrenia:
1. Who have shown partial or complete resistance to typical or atypical drug therapy
2. Are right handed
3. Have no history of neurological conditions or head injury
4. Can tolerate scanning
5. Can provide written consent
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Participants - exclusion criteria
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Evidence of primary drug or alcohol abuse or consumption of alcohol or street drugs within 24 hours of scheduled testing.
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Anticipated start date
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01/11/2002
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Anticipated end date
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30/03/2007
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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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100
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Interventions
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Functional Magnetic Resonance Imaging (MRI) will be applied to investigate brain functions of 60 patients with schizophrenia, 30 of whom will undergo cognitive behaviour therapy. All patients will be scanned twice, 8 to 9 months apart, during a series of tasks known or likely to be sensitive to symptoms of schizophrenia.
Control data will also be obtained from 20 patients with schizophrenia who have shown a good response to their antipsychotic medication and 20 healthy subjects.
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Primary outcome measure(s)
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1. Blood-oxygenation-level-dependent response in cortical and sub-cortical regions
2. Symptom scores
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 067427)
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Trial website
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Publications
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Contact name
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Dr
Veena
Kumani
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Address
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King's College London
Institute of Psychiatry
PO78, Psychology
De Crespigny Park
Denmark Hill
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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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Tel
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+44 (0)20 7848 0233
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Fax
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+44 (0)20 7848 0860
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Email
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v.kumari@iop.kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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c/o Dr Gill Dale
Research and Development Office P005
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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Tel
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+44 (0)20 7848 0675
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Fax
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+44 (0)20 7848 0147
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Email
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g.dale@iop.kcl.ac.uk
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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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22/07/2005
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Last edited
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08/11/2011
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Date ISRCTN assigned
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22/07/2005
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