Neural correlates of response to COGnitive behaviour therapy in SCHIZophrenia: a functional magnetic resonance imaging investigation

ISRCTN	ISRCTN35852420
DOI	https://doi.org/10.1186/ISRCTN35852420
Secondary identifying numbers	067427

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Veena Kumari
Scientific

King's College London
Institute of Psychiatry
PO78, Psychology
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0233
Email	v.kumari@iop.kcl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	COGSCHIZ
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Blood-oxygenation-level-dependent response in cortical and sub-cortical regions 2. Symptom scores
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/11/2002
Completion date	30/03/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Key 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
Key exclusion criteria	Evidence of primary drug or alcohol abuse or consumption of alcohol or street drugs within 24 hours of scheduled testing.
Date of first enrolment	01/11/2002
Date of final enrolment	30/03/2007

King's College London

London
SE5 8AF
United Kingdom

King's College London (UK)
University/education

c/o Dr Gill Dale
Research and Development Office P005
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Charity

The Wellcome Trust (UK) (grant ref: 067427)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011		Yes	No