Psilocybin Medicine Open-Label Study (PMOS): a determination of the safety and efficacy of psilocybin-assisted psychotherapy for patients with Treatment Resistant Major Depressive Disorder (TRD) within an Australian clinical context.

Inclusion Criteria13

• Adults aged 18 years or older;
• Understanding of English (with interpreter if needed) who have provided, or have capacity to provide informed consent;
• Are capable of conforming to study related procedures;
• Participants with a medical history of Major Depressive Disorder (SCID-5) and are currently experiencing a major depressive episode with low risk of suicidality;
• Participants with a baseline GRID-HAMD score greater than or equal to 20, indicating moderate-severe depression;
• Participants must have failed to respond to achieve a clinical response to two or more adequate courses of antidepressants, preferably across at least two different classes of medication for a minimum of three weeks at the minimum effective dose. The definition of ‘failed to respond’ is an inadequate response to an adequate duration and dose, or failure to reach an adequate dose and duration due to lack of tolerance;
• Participants who are attending psychotherapy that has been stable for at least two months prior to screening and is expected to remain stable for the duration of the study;
• Participants must be clinically stable as determined by screening for medical problems via a personal interview, a health questionnaire, a physical examination, an electrocardiogram (ECG), and clinical laboratory screening such as blood tests and urinalysis; (ECG and bloods will be collected by a private provider, not by GoodMind Therapeutics)
• Patient should be willing to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days;
• Participants should refrain from using any psychoactive drugs or illicit substances, including alcoholic beverages and nicotine, within 48 hours of each psilocybin administration (with the exception of caffeine);
• Participants should be compliant with not taking any medicines that are only ‘used when needed’ or PRN on the mornings of drug sessions or the night prior;
• Participant should be willing to refrain from taking any non-prescription medication, nutritional supplement, or herbal supplement, one week before each drug session, except when approved by the study investigators (exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and doses of common vitamins and minerals);
• Have minimal hallucinogen use in the past five years and a total hallucinogen use less than 10 times.