Generalized Anxiety Disorder MedDRA version: 9.1 Level: LLT Classification code 10018075 Term: Generalised anxiety disorder
Conditions
Interventions
Trade Name: Lorazepam Tablets 1mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: LORAZEPAM
CAS Number: 846491
Current Sponsor code:
Sponsors
University of Bristol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Age between 19 and 40 years 3. Body weight >60kg. 4. No abnormality on clinical examination, including a history of presence of cardiac, ophthalmologic, gastro-intestinal, hepatic, or renal disease or other condition known to increase risk of side effects. 5. No clinically significant abnormality on clinical chemistry or haematology or ECG examination at screening prior to study. 6. Negative urine drug screen at the clinical screening and on the day of each inhalation session (4 sessions in all). 7. No abuse of alcohol defined as an average intake of greater than 21 units per week or 3 units per day. One unit is equivalent to a half pint of beer or 1 measure of spirits or 1 glass of wine. 8. If participants usually consume a caffeinated drink in the morning they will be asked not to consume more than one cup of their normal volume and not to consume it within 2 hours of the beginning of the session. 9. No history or presence of neurological or psychiatric conditions (e.g. stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, major depression, generalise anxiety disorder etc.). 10. No history of panic attacks or severe anxiety. 11. No history of claustrophobia. 12. No history of, or current condition of, migraine headaches. 13. Subjects will be instructed to eat a light meal at least 1 hour before attending the research unit. 14. No previous experience of the CO2 procedure 15. A negative breathalyzer test on the day of the test session (4 sessions in all) 16. Subjects have given informed consent 17. Do not have needle or blood phobia. 18. Non smoker or light smoker (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Are female 2. Have received prescribed medication within 14 days prior to the first dosing (drug or placebo), which in the opinion of the medical consultant conducting the screening may interfere with the study procedures or compromise safety. 3. Have received over-the-counter (OTC) medicine within 48 hours before the beginning of the session. Subjects who have taken OTC medication may still be entered into the study, if, in the opinion of the medical consultant, the medication received will not interfere with the study procedures or compromise safety. 4. Have a personal, or have a close family member with, a history of panic disorder or an anxiety disorder. 5. Have participated in a trial with any drug within 84 days before start of study. 6. Have a positive urine test for psychoactive drugs e.g. cannabis. 7. Have a positive alcohol breath test (> 20mgl 100 ml of blood) on the morning of the test day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine whether levels of the drug, lorazepam, in the blood are related to the size of its anxiolytic effects e.g. the more lorazepam in the blood the more relief from anxiety it provides. ;Primary end point(s): To evaluate the effects of lorazepam (0.5 and 2.0 mg) on emotional indices of anxiety and panic induced by CO2 (7.5%) or air breathing for 20 minutes. ;Main Objective: A human model of GAD will be useful to investigate how GAD symptoms occur, and to test potential medications in healthy volunteers and in patients. To be effective, any potential model needs to reliably reproduce anxiety in healthy people and the degree of anxiety provoked should be repeatable and measurable. In addition the effects of known anxiolytics should mirror those in patients. We have developed a possible model of GAD using the inhalation of increased levels of carbon dioxide (7.5% CO2) for 20 minutes (Bailey et, al 2005). In healthy volunteers, this challenge induces anxiety and increases blood pressure and heart rate. To further validate the 7.5% CO2 challenge as a model of GAD, it is essential to know whether the dose of lorazepam required to alleviate anxiety is similar between subjects in the model and patients with GAD. This model could then be used to test the effectiveness of potential medications on GAD and stress. | — |
Countries
United Kingdom
Outcome results
None listed