Interest in psychedelic-assisted and psychedelic-derived therapies continues to grow as new clinical trials, state initiatives, and federal actions expand discussion around their potential role in mental health treatment. Most recently, findings were published from a Phase 3 clinical trial of DT120, a pharmaceutical formulation of lysergide (LSD), for the treatment of major depression.
Approximately 149 patients with major depressive disorder (MDD) were enrolled in the trial and given either placebo or 100 micrograms of DT120 for 12 weeks. In both scenarios, patients were monitored by attendants who chaperoned them through eight-hour therapy sessions. The primary endpoints of the study were changes in depression, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), which quantifies depression symptoms into a point scale.
MADRS changes from baseline were assessed at six and 12 weeks after dosing. Twelve weeks after dosing, a MADRS score reduction of 7.1 was reported for those taking DT120, a significant achievement as analysts had previously claimed that a four-to-five-point reduction would be considered a strong outcome.
When adjusted to a placebo, DPT120 demonstrated an 8.1 reduction in MADRS points. This is particularly notable, as the second-highest reduction in MADRS points was a 6.8-point reduction from Spravato, a ketamine-derived drug that is FDA-approved for severe and hard-to-treat depression.
DT120 appears to be well-tolerated, with 99% of adverse events mild to moderate, occurring mainly on the day of dosing and with no serious safety issues or increases in suicidal thoughts observed.
Ongoing clinical research surrounding psychedelics have shown their potential to treat certain mental health conditions, and these trial results come at an eventful point in time for psychedelic therapy. In May, the White House issued an Executive Order intended to accelerate the development, review, and potential access to novel psychedelic treatments for serious mental illnesses, and throughout 2026 several states continue to enact bills that embrace pilot programs to increase access to psychedelic therapies.
A second late-stage depression trial with DT120 is currently running and the manufacturer, Definium Therapeutics, is optimistic that the results will help prepare the drug for FDA submission. Additionally, two Phase 3 trials are underway testing DT120 for generalized anxiety disorder.
