Randomised, double-blind, active-placebo-controlled Phase II trial (n=60) of two-session LSD-assisted psychotherapy (100 µg → 100/200 µg) versus low-dose LSD (25 µg ×2) for Major Depressive Disorder.
This randomised, double-blind, parallel-group trial tests LSD-assisted psychotherapy in patients with Major Depressive Disorder using two dosing sessions and an active low-dose comparator.
Sixty participants aged over 25 will receive psychotherapy with either moderate/high-dose LSD (100 µg then 100 or 200 µg) or low-dose LSD (25 µg in both sessions); outcomes include depressive symptoms (IDS, BDI), anxiety (STAI) and general psychopathology (SCL-90).
Masking is quadruple and the trial is registered on ClinicalTrials.gov (NCT03866252); primary purpose is treatment.
Two-session LSD-assisted psychotherapy: 100 µg in session 1; session 2 100 µg or 200 µg (dose escalation).
Session 1 100 µg; session 2 100 or 200 µg per protocol; oral administration paired with psychotherapy.
Two-session active-placebo (low-dose LSD) with psychotherapy.
25 µg LSD in both sessions as active-placebo comparator.
This double-blind controlled trial (n=61) found that high-dose LSD-assisted therapy (100μg + 200μg) reduced depression symptoms more than low-dose LSD (25μg + 25μg) in patients with moderate-to-severe major depressive disorder (MDD), with benefits lasting up to 12 weeks and similar side effects between groups.