A Phase 2a Study of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients with MDD.
Research type
Research Study
Full title
A Phase 2a Study to Evaluate the Safety and Tolerability of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients with Major Depressive Disorder.
IRAS ID
1008480
Contact name
Jason Winters
Contact email
Sponsor organisation
Gilgamesh Pharmaceuticals
Eudract number
2023-000846-40
Research summary
The purpose of this study is to test an investigational (unapproved) drug called GM-2505 (study drug) that is being developed for the treatment of Major Depressive Disorder (MDD).
GM-2505 is a newly developed serotonergic psychedelic drug, acting primarily as an agonist at 5-HT2a receptors and also promoting serotonin release. Its effects are expected to be similar to other well known psychedelic drugs such as psilocybin (the main psychoactive component in magic mushrooms) and N,N-dimethyl tryptamine (DMT).
The study will enrol up to 40 MDD patients across 3 non-NHS clinical trial units. Participants will attend the clinical unit for screening and if eligible, will be enrolled into the study. The participants will be randomised to one of two parallel study arms at a 1:1 ratio. Each patient will receive two different doses of GM-2505 via IV infusion, with 2-weeks in between each dose. The first dose will either be a low dose (minimal psychedelic effect) or moderate dose (with psychedelic effect) of GM-2505. After two weeks of washout, the patient will receive a high dose of GM-2505 with robust psychedelic effect.
Study procedures will include blood sampling for assessment of PK and safety, ECG, vital signs, rsEEG; in addition, participants will be required to complete a number of questionnaires and scales to assess their mental and physiological state throughout the study. There is also an optional pharmacogenetics blood sample at Day 1, assessment is optional and additional consent for the procedure will be gained.The estimated duration of participation in the study is approximately 14 weeks, from screening to final follow up visit.
REC name
Wales REC 1
REC reference
23/WA/0218
Date of REC Opinion
24 Nov 2023
REC opinion
Further Information Favourable Opinion