Condition category
Mental and Behavioural Disorders
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
02/06/2015
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 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

http://www.cpft.nhs.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

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

Publication citations

Additional files

Editorial Notes