Condition category
Mental and Behavioural Disorders
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
01/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.iop.kcl.ac.uk

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

  1. 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.

Additional files

Editorial Notes