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.

Topic Depression Microdosing
Compound LSD
Country New Zealand
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Trial Details



Trial Number

Sponsors & Collaborators

University of Auckland
The University of Auckland is engaged in research on the therapeutic uses of psychedelic drugs, focusing on substances like LSD, ketamine, and MDMA to address mental health issues.

MindBio Therapeutics
MindBio Therapeutics is conducting clinical research exploring the effects of microdosing psychedelic medicines to treat a range of medical conditions such as depression, anxiety, PTSD, panic disorder, chronic pain and opioid addiction.

Papers

LSD microdosing in major depressive disorder: results from an open-label trial
This open-label Phase IIa trial (n=19, 15 male) found that an 8-week regimen of microdosed LSD (8μg initially, then 6-20μg twice weekly) for major depressive disorder was well-tolerated with no serious adverse events or cardiac valvulopathy, achieved 59.5% reduction in MADRS scores sustained for six months, and had only one withdrawal due to anxiety.

Data attribution

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