Further development of a new model of GAD: The effect of a clinically effective and non-effective dose of lorazepam on CO2 induced anxiety - Determining the dose effect of lorazepam on CO2 induced anxiety

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10018075 Term: Generalised anxiety disorder; Generalized Anxiety Disorder

• Registration Number: EUCTR2006-001085-17-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-26
• Study Completion: 2008-08-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 18

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 (< 5 cigarettes per day ). Participants should not smoke for 2 hours prior to study visits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified