Investigating the neural basis of inhibition, set-shifting and monitoring in obsessive-compulsive disorder (OCD), attention-deficit hyperactivity disorder (ADHD) and healthy volunteers

ISRCTN	ISRCTN75690327
DOI	https://doi.org/10.1186/ISRCTN75690327
Secondary identifying numbers	6443

Submission date: 30/07/2010
Registration date: 30/07/2010
Last edited: 04/10/2017

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mercedes Arroyo
Scientific

Behavioural and Clinical Neuroscience Institute
Department of Psychiatry
University of Cambridge
Downing Street
Cambridge
CB2 3EB
United Kingdom

Email	ma10027@cam.ac.uk

Study information

Study design	Multicentre non-randomised interventional diagnosis and process of care trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Investigating the neural basis of inhibition, set-shifting and monitoring in obsessive-compulsive disorder (OCD), attention-deficit hyperactivity disorder (ADHD) and healthy volunteers
Study objectives	The purpose of these experiments is to investigate the relationship between dysfunction in different but related executive processes including set-shifting, inhibition and monitoring in obsessive-compulsive disorder (OCD) and attention-deficit hyperactivity disorder (ADHD). Moreover, the study aims to clarify the precise neural substrates of the above executive functions currently conceived of s separate yet related. To this end, a battery comprising of distinct yet converging tasks examining the three components of executive functions has been designed, specifically targeting set-shifting, response inhibition and performance monitoring. The design will contrast behavioral, blood-oxygen-level-dependent (BOLD) activation and brain structure between the ADHD group and its age and education matched control group and between the OCD group and its age and education matched control group. Each task will be analysed separately. The four groups will also enter into combined analyses to contrast the two patient groups directly. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6443
Ethics approval(s)	MREC approved ref: 08/H308/65
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Attention deficit hyperactivity conduct disorder; Disease: Attention deficit hyperactivity disorder; conduct disorders
Intervention	1. Face to face interview: once, approximately 10 minutes duration 2. Imaging (not radiation): twice, 1 hour each time; each participant will undergo functional magnetic resonance imaging (fMRI) 3. Telephone interview: once, approximately 20 minutes duration
Intervention type	Mixed
Primary outcome measure	Blood oxygenation level dependent (BOLD) response due to neural activity.
Secondary outcome measures	Reaction times and button choices to the stimuli being presented while in the scanner and questionnaire responses.
Overall study start date	01/04/2008
Completion date	01/04/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Planned sample size: 120
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2008
Date of final enrolment	01/04/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Cambridge

Cambridge
CB2 3EB
United Kingdom

Sponsor information

Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Hospital/treatment centre

Cambridge Road
Fulbourn
Cambridge
CB21 5EF
England
United Kingdom

Website	http://www.cpft.nhs.uk/
"ROR"	https://ror.org/040ch0e11

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations

Location: United Kingdom

Results and Publications

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

Editorial Notes

04/10/2017:No publications found in PubMed, verifying study status with principal investigator.