Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
03/03/2015
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 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes