Microdosing LSD For Major Depression Treatment Seeks Further Clinical Validation Via New Study

Australian psychedelics company MindBio Therapeutics Corp. was granted approval by both the Ethics committee and the Clinical Trials Registry to begin the world's first Phase 2a take-home LSD microdosing trial in patients with Major Depressive Disorder (MDD).

MDD is reportedly the leading cause of global disability, with over 260 million people affected. 

MindBio is viewed as one of the businesses most committed to the advancement of LSD microdosing trials, a psychedelic-based treatment that “proposes to be a globally scalable solution to treating mental health conditions,” as CEO Justin Hanka defined it.

In Aotearoa, NZ, where the study will take place, approximately 6% of the total population experiences a yearly depressive episode. In the U.S., the CDC predicts about 16 million adults will experience depression each year. 

Existing medication is limited by slow onset, variable tolerability and a partial or total lack of efficacy in around 30% of patients. While people taking antidepressants report feeling helped with their mood, problems mount regarding withdrawal, sexual dysfunction, weight gain and emotional numbing, all of which affect quality of life.

In 2022, MindBio's Phase 1 take-home LSD microdosing trial in 80 healthy participants yielded positive topline results, including the patient arm that effectively received the psychedelic experienced increases in happiness, social connectivity, creativity, wellness and energy in dose days.

This open-label Phase 2 study will assess the tolerability and feasibility of an 8-week LSD microdosing regime in 20 patients with MDD. 

If the results are positive, the trial will be followed by a “much larger” (TBD) Phase 2b randomized, triple-dummy, active, placebo-controlled one also in patients with MDD.

Another soon-to-begin Phase 2 study for the company is to assess treatment for patients with advanced-stage cancer. 

Photo: Benzinga edit with photo by Romolo Tavani and Sendo Serra on Shutterstock.