Contact information
Type
Scientific
Primary contact
Dr Veena Kumari
ORCID ID
Contact details
King's College London
Institute of Psychiatry
PO78
Psychology
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0233
v.kumari@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
067427
Study information
Scientific title
Acronym
COGSCHIZ
Study hypothesis
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.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Blood-oxygenation-level-dependent response in cortical and sub-cortical regions
2. Symptom scores
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2002
Overall trial end date
30/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Evidence of primary drug or alcohol abuse or consumption of alcohol or street drugs within 24 hours of scheduled testing.
Recruitment start date
01/11/2002
Recruitment end date
30/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Dr Gill Dale
Research and Development Office P005
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0675
g.dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 067427)
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21772062
Publication citations
-
Results
Kumari V, Fannon D, Peters ER, Ffytche DH, Sumich AL, Premkumar P, Anilkumar AP, Andrew C, Phillips ML, Williams SC, Kuipers E, Neural changes following cognitive behaviour therapy for psychosis: a longitudinal study., Brain, 2011, 134, Pt 8, 2396-2407, doi: 10.1093/brain/awr154.