A trial to assess the effects and safety of SYT-510 treatment in people with anxiety
Research type
Research Study
Full title
A study investigating the efficacy, safety, tolerability, and pharmacokinetics of a single dose of SYT-510 in participants who meet DSM-5 diagnostic criteria for generalized anxiety disorder
IRAS ID
1013320
Contact name
George Garibaldi
Contact email
Sponsor organisation
Synendos Therapeutics AG
Clinicaltrials.gov Identifier
Research summary
The trial medicine is an experimental treatment for a variety of central nervous system (CNS) disorders and aims to improve symptoms of generalised anxiety disorder (GAD). People with GAD often worry a lot about everyday things that there is no reason to be worried about. As a result, they may have difficulty sleeping or concentrating, feel restless or nervous, get easily tired or irritated, and/or have tense muscles. We hope that the trial medicine will work by regulating the amount of substances in the brain, called neurotransmitters, that allow cells in your brain to communicate. Specifically, we hope the study medicine will increase the amount of a type of neurotransmitters called endocannabinoids, which help to regulate many brain functions, such as mood, appetite, and sleep, and how you experience pain.
We’ll give up to 24 participants diagnosed with GAD a single dose of the trial medicine or placebo in each treatment session. Each participant will receive both treatments (trial medicine and placebo) in two separate treatment sessions; the participants will not know during which session they will receive the active medication or the placebo.
Participants will take about 11 weeks to finish the trial, from screening to follow-up. They’ll have 2 treatment sessions, separated by a washout period. In each session, they’ll stay on the ward for 1 night and have 1 ‘remote’ visit, where they’ll complete a questionnaire, at home.
A pharmaceutical company, Synendos Therapeutics AG is funding the trial.
The trial will take place at 1 centre in London.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0209
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion