Serotonin 1A biased agonism and reward processing (STAR study)
Research type
Research Study
Full title
The effect of post-synaptic 5-HT1A biased agonism on affective, reward and memory processing in healthy volunteers
IRAS ID
309406
Contact name
Susannah Murphy
Contact email
Sponsor organisation
Research Governance, Ethics & Assurance
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The purpose of this study is to understand more about the role of the brain chemical serotonin in cognitive processes, such as learning, attention, and responses to emotional or rewarding information. Most drugs that affect serotonin in the brain (such as SSRIs, which are commonly used as antidepressants) have a broad effect, increasing levels of serotonin across the brain. However, there are some drugs which only affect the function of a subset of serotonin receptors. These kinds of drugs might be a useful in the treatment of a range of illnesses, including depression, anxiety and cognitive impairment. This study will explore whether one such drug targeting a particular serotonin receptor – the 5-HT1A receptor - has effects on cognition in healthy volunteers. This is a useful way to understand more about this receptor and it might be a useful target for future treatment development.
This study will include healthy male volunteers, who have no history of psychiatric illness. Participants will undergo initial screening to check that they are suitable to take part in the study. They will then be allocated randomly to a single dose of NLX-101 or a dummy (placebo). A few hours later, participants will be asked to complete a number of psychological tests. Testing will involve completion of several computer tasks involving the interpretation of emotion and reward, as well as memory tests. To understand more about the role of 5-HT1A receptors in humans, a comparison will be made between task performance in the NLX-101 group and placebo group. To date, safety testing of NLX-101 has only been completed in males, so this study will not include female participants.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0132
Date of REC Opinion
27 Jun 2023
REC opinion
Further Information Unfavourable Opinion