Effects of BNC210 on human brain activity in anxious subjects
Research type
Research Study
Full title
A randomized, double-blinded, placebo and lorazepam-controlled, four-way crossover, Phase II study to evaluate the effects of single oral administration of BNC210 on brain activity changes captured by functional magnetic resonance imaging in adults with Generalized Anxiety Disorder
IRAS ID
168853
Contact name
Allan Young
Contact email
Sponsor organisation
Bionomics Ltd
Eudract number
2014-004937-15
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Anxiety disorders cause suffering to millions of people every year. Existing drugs are effective against anxiety but have sedative side effects that can cause problems in the daily lives of anxiety disorder sufferers, for example impairing the safe operation of heavy machinery or automobiles. This study will investigate the effect on brain activity of a new type of anti-anxiety drug that is non-sedating. We will examine the effect of BNC210 on anxiety-related brain activity. BNC210 is being developed by Bionomics Ltd. who is funding this study. The effects of BNC210 will be compared to placebo. An established anti-anxiety drug (lorazepam) will be used as a positive control. The theoretical roots of this study lie in Jeffrey Gray’s explanation of trait anxiety in terms of sensitivity to punishment. Gray based his theory on the finding that anti-anxiety drugs not only reduce clinical anxiety but also dampen punishment-related behaviour in rodents. This theory means that if BNC210 is successful in engaging anxiety-related brain systems it should alter the activity of brain systems that govern threat-avoidance behaviour. We will use Functional Magnetic Resonance Imaging to monitor the brains of 24 male and female participants who meet criteria for Generalized Anxiety Disorder but are otherwise fit and healthy, while they perform two tasks which have previously been found to activate anxiety-related brain systems: 1) the Joystick Operated Runway Task to measure threat-avoidance behaviour; 2) the Emotional Faces Task. If we find that BNC210 systematically modulates anxiety-related brain activity more strongly than placebo during these tasks, we will have put in place an important piece of evidence in favour of BNC210 having capacity to bring relief to sufferers of anxiety disorders. Participants will attend the site for 5 visits. The first is a screening visit which is followed by four day-long visits. At two visits they will receive a single dose of BNC210 and lorazepam placebo, at one visit they will receive BNC210 placebo and a single dose of lorazepam, and at one visit they will receive placebo for both BNC210 and lorazepam. Each participant will take between 6 and 12 weeks to complete the study.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/2127
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion