Assessing the effects of Lysergic acid diethylamide (LSD) microdosing in people experiencing depression (LSDDEP1)

This open-label pilot trial (n=20) aims to evaluate the tolerability and feasibility of LSD microdosing in patients with major depressive disorder (MDD).

Led by A/Prof Suresh Muthukumaraswamy from The University of Auckland, the study involves sublingually administering Lysergic acid diethylamide (LSD) solution in two doses every week for eight weeks, starting at 8 mcg with a pre-defined titration schedule. The dose will be adjusted based on participant tolerance.

Primary outcomes include the percentage of participants completing the dosing regimen and the percentage of attended clinic visits. Secondary outcomes involve assessing depressive symptoms using the Montomery-Asberg Depressive Rating Scale (MADRS).

Eligible participants must have a diagnosis of MDD, be aged between 21 to 65 years, and meet specific criteria outlined in the DSM-5. Exclusion criteria include conditions such as schizophrenia, bipolar disorder, and substance dependence.

The trial is a non-randomised, phase II study conducted in New Zealand, funded by the Health Research Council of New Zealand and MindBio Therapeutics Ltd. Ethics approval was obtained from the Southern HDEC. Recruitment commenced in August 2023, with a target of 20 participants. The principal investigator can be contacted for further information.

You can find the study protocol here.

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 recently published Phase 1 study in healthy volunteers (https://pubmed.ncbi.nlm.nih.gov/36997080/; ACTRN12621000436875) , we determined that LSD microdosing was relatively safe in this cohort and well-tolerated. Further the data demonstrate that conducting such microdosing studies is feasible with excellent adherence and compliance to regimen observed. In this open-label pilot trial with patients with major depressive disorder (MDD) we will test the tolerability and feasibility of an 8 week regimen of LSD microdosing in this patient group.

Trial Number ACTRN12623000486628

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.