Assessing the effects of Lysergic acid diethylamide (LSD) microdosing in people experiencing depression (LSDDEP2)

This randomised, double-dummy, triple-blind, placebo-controlled, parallel groups trial (n=90) investigates the effects of LSD microdosing (2-20μg) in patients with major depressive disorder (MDD) compared to an active placebo.

Administered sublingually, participants receive two doses of LSD or placebo weekly for eight weeks, with a starting dose of 8 mcg and a range of 2-20 mcg. Adherence is monitored through video recordings of each dose administration.

Primary outcome measures include the total score of the Montgomery-Asberg Depressive Rating Scale (MADRS) and secondary outcomes involve various assessments of anxiety, depression, stress, anhedonia, ruminative response, and quality of life.

Eligible participants, aged 21-65, must have a diagnosis of MDD according to DSM-5 criteria and a MADRS score between 18-35. Exclusion criteria include certain psychiatric disorders, substance dependence, suicidal risk, and other medical conditions.

The trial is conducted by the University of Auckland, New Zealand, with funding from the Health Research Council of New Zealand and MindBio Therapeutics Ltd. Ethics approval was granted by Southern HDEC, New Zealand, on 14/12/2022. The trial aims to address the need for new antidepressant therapies, given the challenges with existing treatments and the emerging trend of self-medicating depression with psychedelic microdoses.

Trial Details

Depressive disorders are the leading cause of “years lived with disability” in New Zealand and there is a clear need for the development of new, alternative antidepressant therapies. In light of problems with the tolerability and efficacy of available treatments, a global trend is emerging for patients to self-treat depression with microdoses of psychedelic drugs such as lysergic acid diethylamide (LSD) and psilocybin. Beyond anecdotal reports from those who self-medicate in this way, there are few clinical trials that have evaluated this practice. In our recent Phase 1 study in healthy volunteers (ACTRN12621000436875) , we determined that LSD microdosing was relatively safe in this cohort and well-tolerated. Further data (ACTRN12623000486628) demonstrated that LSD microdosing is feasible and well tolerated in patients with depression. In this randomised controlled trial with patients with major depressive disorder (MDD) we will test the efficacy of an 8 week regimen of LSD microdosing in this patient group versus an active placebo to treat depressive symptology

NCT Number ACTRN12624000128594

Data attribution

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