An open-label pilot trial assessing tolerability and feasibility of LSD microdosing in patients with major depressive disorder (LSDDEP1)

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

Participants, aged 21-65, diagnosed with MDD as per DSM-5 criteria, will receive sublingually administered Lysergic acid diethylamide (LSD) solution for eight weeks, with doses starting at 8 mcg and titrated according to a predefined schedule. Adherence will be monitored through video recordings of dose administration.

The primary outcomes include the percentage of participants completing the dosing regimen and attending clinic visits. Secondary outcomes involve assessing depressive symptoms using the Montgomery-Asberg Depressive Rating Scale (MADRS).

The study is conducted in New Zealand, with the University of Auckland as the primary sponsor. Recruitment began on 14/08/2023, and the anticipated date of last data collection is 8/08/2024. The trial is funded by the Health Research Council of New Zealand and MindBio Therapeutics Ltd. The principal investigator is Prof Suresh Muthukumaraswamy.

Topic Treatment-Resistant Depression Depression Microdosing
Compound LSD
Country New Zealand
Visit trial
Status Recruiting
Results Published No
Start date 14 August 2023
End date 08 August 2024
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 21- 65
Therapy No

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.

NCT Number ACTRN12623000486628

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.

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.