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| Further Development of a New Model of Generalised Anxiety Disorder: Effects on Processing of Emotional Material |
| Source of record | UK Trials |
| ISRCTN | ISRCTN76669810 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0264192826 |
| Public title | Further Development of a New Model of Generalised Anxiety Disorder: Effects on Processing of Emotional Material |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: General anxiety disorder |
| 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 (ie are changes in the physical response to CO2 related to changes in the psychological response?). |
| Design/methodology | Double blind, placebo-controlled, randomised crossover study in healthy volunteers |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/01/2007 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | 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. |
| Primary outcome measure(s) | The difference between air and 7.5% CO2-enriched air on measures of processing of emotional information. |
| Secondary outcome measure(s) | The difference between air and 7.5% CO2-enriched air on subjective measures of anxiety and cardiovascular function. |
| Sources of funding | United Bristol Healthcare NHS Trust NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall London United Kingdom SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Marcus Munafo |
| Contact details | C/O Research and Effectiveness Department Level 1, Old Building Bristol Royal Infirmary Marborough Street Bristol United Kingdom BS2 8HW |
| Contact telephone | +44 0117 928 3473 |
| Contact fax | +44 |
| Contact email | R&E@ubht.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN76669810 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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