Acute stress Mental and Behavioural Disorders Acute stress
Conditions
Interventions
We aim to understand how the brain is activated by acute stress. Acute stress has a number of effects that modulate body and brain function in health and disease
these effects have positive and negative consequences that impact on personal well being. For instance the acute stress response facilitates the body's ability to deal with unexpected and extraordinar
however, if prolonged, it can also precipitate disease processes in predisposed individuals.
Understanding the changes in brain activity induced by increases in corticosteroids will underpin knowledg
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males, right handed, age 18-50 inclusive 2. Healthy as determined by medical history and physical examination 3. Body weight > 50 kg and <120 kg 4. Standard clinical laboratory tests within normal reference range for the population, investigator site or, results with acceptable deviations that are judged to be not clinically significant by the investigator 5. Normal blood pressure and heart rate as determined by the investigator 6. Have given written informed consent approved by the Ethical Committee
Exclusion criteria
Exclusion criteria: 1. Females; males outside 18-50 age range 2. As a result of the medical interview, physical examination or screening investigations (haematology, clinical chemistry including random blood sugar), the physician responsible considers the subject unsuitable for the study. In particular a blood sugar of >8 mmol/l is an explicit exclusion criterion. 3. The subject has a history or presence of drug or other significant allergy that, in the opinion of the responsible physician, contra-indicated their participation. 4. The subject has participated in a clinical study with an investigational or a non-investigational drug or medical device during the previous three months or has participated in more than three studies in the previous year. 5. The subject has a history or presence of any illness (cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders) capable of significantly altering brain responses to hydrocortisone. 6. History of psychiatric or neurological disorder which, in the investigator?s opinion, is likely to influence the experiment, or compromise safety. 7. The subject has history of presence of seizures or risk factors for seizure. 8. History of aspirin-sensitive asthma or nasal polyposis. 9. Use of drugs with known vasodilator or vasoconstrictor activity and intra-nasal steroids/anti-histamines within seven days of or five half lives (whichever was the longer) prior to any study day. 10. The subjects has used or is using other regular prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within seven days or five half lives (whichever was the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication would not have interfered with the study procedures or compromised subject safety. 11. The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BOLD MR brain signal in the 60-90 minutes after administration of hydrocortisone or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Arterial Spin Labelling brain signal after administration of hydrocortisone or placebo 2. Correlation of measures of brain function with pharmacokinetic (plasma levels and receptor translocation measures), pharmacodynamic (pulse, blood pressure, visual analogue scales) and baseline measurements (anxiety scales) | — |
Countries
United Kingdom
Outcome results
None listed