Contact information
Type
Scientific
Primary contact
Dr Mercedes Arroyo
ORCID ID
Contact details
Behavioural and Clinical Neuroscience Institute
Department of Psychiatry
University of Cambridge
Downing Street
Cambridge
CB2 3EB
United Kingdom
-
ma10027@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6443
Study information
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
Acronym
Study hypothesis
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
MREC approved ref: 08/H308/65
Study design
Multicentre non-randomised interventional diagnosis and process of care trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/04/2008
Overall trial end date
01/04/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 120
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2008
Recruitment end date
01/04/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge
Cambridge
CB2 3EB
United Kingdom
Sponsor information
Organisation
Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Sponsor details
Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
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