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 |
| Protocol serial number | 067427 |
| Sponsor | King's College London (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 067427) |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 01/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Veena Kumari
Scientific
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 |
|---|---|
| v.kumari@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Blood-oxygenation-level-dependent response in cortical and sub-cortical regions |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College London
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No |
