SPL026 With or Without SSRIs in Participants With MDD

This open-label trial (n=24) investigates the difference between those who are and aren’t taking antidepressants (SSRIs) who will receive SPL026 (DMT fumarate). As a Phase I study, the main concern is safety and tolerability. With 24 participants, some signal on effectiveness might be detected.

Topic Safety Depression
Compound DMT
Country United Kingdom
Visit trial
Status Not yet recruiting
Results Published
Start date 01 October 2022
End date 01 February 2023
Chance of happening 80%
Design Open
Type Interventional
Generation Second
Participants 24
Sex All
Age 18- 99
Therapy No

Trial Details

The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine [DMT] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.

NCT Number NCT05553691

Sponsors & Collaborators

Small Pharma
Small Pharma works on the development of two drugs. Together with Imperial College London they are developing intravenous administration DMT. The other project is a variant on ketamine (SPL801B).

Data attribution

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