Contact information
Type
Scientific
Primary contact
Dr Marcus Munafo
ORCID ID
Contact details
C/O Research and Effectiveness Department
Level 1
Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
R&E@ubht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0264192826
Study information
Scientific title
Further development of a new model of generalised anxiety disorder: effects on processing of emotional material
Acronym
Study hypothesis
This study will enable us to learn more about how the inhalation of carbon dioxide (CO2) produces anxiety. We can examine the psychological mechanisms of CO2-induced anxiety and see how these influence the processing of emotional material. These findings will aid our understanding of anxiety and validate the CO2 model for use in studies of potential new treatments. It is widely accepted that anxiety results in altered processing of emotional material. Anxiety is also associated with physical symptoms such as racing heart, raised blood pressure, and muscle tension. We aim to examine the relationship between heart rate and blood pressure and altered processing of emotional material (i.e., are changes in the physical response to CO2 related to changes in the psychological response?).
Ethics approval
Not provided at time of registration
Study design
Double-blind placebo-controlled randomised crossover study in healthy volunteers
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mental and Behavioural Disorders: General anxiety disorder
Intervention
One study will be performed, which will be a double blind, placebo-controlled, randomised crossover study in healthy volunteers. Participants will complete a single test session, which will consist of the inhalation of air and the inhalation of 7.5% CO2, in counterbalanced order. Twenty healthy male and female non-smoking participants, aged between 18 and 55, with a normal medical and psychiatric history, physical examination and ECG will be recruited.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The difference between air and 7.5% CO2-enriched air on measures of processing of emotional information.
Secondary outcome measures
The difference between air and 7.5% CO2-enriched air on subjective measures of anxiety and cardiovascular function.
Overall trial start date
01/01/2007
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female participants
2. Aged 18-55
3. With a normal medical and psychiatric history, physical examination and ECG who give signed, fully-informed consent to participate
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Females who are pregnant, breastfeeding, or not using adequate contraception
2. Presence of any pathological condition
3. Personal history of current or past psychiatric illness by psychiatric interview
4. Strong family history of mood disorder, including panic disorder
5. Personal history of cardiovascular or respiratory disease, including asthma
6. Personal history of migraine headaches requiring treatment
7. Cigarette smoking in the last 6 months
8. Drinking more than the recommended units of alcohol per week
9. Personal history of alcoholism or drug dependence
10. Drinking more than 8 caffeinated drinks per day
11. Medication use (except local treatment, or aspirin or paracetamol) within 8 weeks of testing
12. Potential, in the opinion of the investigator, to be non-compliant with study
Recruitment start date
01/01/2007
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
United Bristol Healthcare NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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