SDI-118 phase Ib in participants in remission from depression
Research type
Research Study
Full title
A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics including Cognitive Function in Male and Female Participants in Remission from Depression
IRAS ID
291636
Contact name
Jonathan Savidge
Contact email
Sponsor organisation
Syndesi Therapeutics SA
Eudract number
2020-003748-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
The purpose of this study is to determine if a new medication, SDI-118, given daily over 16 to 18 days, compared to placebo, is safe and well tolerated while participants perform various memory, learning and other tasks. The study also aims to determine whether SDI-118 will lead to changes in brain activity (that is the Blood Oxygen Level Dependent or BOLD signal) for individuals that are remitted from depression. This activity will be measured using functional magnetic resonance imaging (fMRI) while participants are performing memory and learning tasks and a task that indicates a potential antidepressant effect of the drug. When someone becomes depressed, their ability to remember and learn becomes impaired. It is also known that this impairment is not just because they are feeling low and lack the motivation, but because they need to make much more effort to complete tasks that they could do easily when they were well. The impairment remains even when the person recovers (remits) from their depression. This can be shown by using a brain scanner that measures changes in BOLD signal while participants perform memory and learning tasks. In these tasks, those individuals in remission from depression are unable to perform as well as controls (no previous episodes of depression). Individuals in remission from depression need a higher level of brain activation to complete the tasks, which is not always sustainable for the duration of each task. Study participants who have recovered from depression will be recruited from the general population and if suitable for the study, they will be asked to attend seven visits. During this time they will either take a new medication (SDI-118, that is not yet on the market) or a dummy drug (placebo).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0439
Date of REC Opinion
15 Jan 2021
REC opinion
Further Information Favourable Opinion