Treatment Resistant Depression Intervention with Psilocybin-assisted Psychotherapy

Inclusion Criteria18

• · Male and female participants 18 - 75 years of age.
• · Have given written informed consent.
• · Currently under the care of a psychiatrist who is able to provide a referral and willing to maintain ongoing oversight of their patient’s clinical care and treatment management throughout the duration of the study.
• · Have a DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode, as confirmed by the study psychiatrist.
• · Failed to clinically respond to at least two different classes of antidepressant medication treatment (despite adequate dose compliance and minimum treatment duration of 6 weeks) during the current major depressive episode. OR failed to respond to at least 75% of adequate trials of antidepressant medications in past episodes, including inadequate response to at least 2 different classes of antidepressants.
• · Have baseline MADRS score greater than or equal to 20.
• · Currently on psychotropic medication for depression (antidepressant and/or antipsychotic), and able to maintain stable psychotropic medications (including stable dose) from time of first psilocybin dose to last psilocybin dose, and at a dose not exceeding the recommended upper dose limit according to the Australian Medicines Handbook.
• · Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable until the final dose of psilocybin.
• · Will have accompanied transport home after treatment sessions and availability of a friend or family member and home-like environment for the 24 hours following psilocybin dosing.
• · Able to engage with psychotherapy.
• · Able to be followed up for entire duration of the study (i.e., planning to remain in Sydney for the duration of the study).
• · In good general medical health as confirmed by study doctor assessment supported with information from GP/referring psychiatrist.
• · Agree to refrain from using any alcoholic beverages or nicotine within 24 hours of each drug administration, and agree to refrain from caffeine for 2 hours before and 6 hours after each drug administration.
• · Agree to only take medications on the mornings of drug sessions that have been approved by the study psychiatrist.
• · Agree to refrain from taking any non-prescription drugs, nutritional supplements, or herbal supplements for one week before each psilocybin administration unless approved by the study psychiatrist.
• · Have none or limited lifetime use of hallucinogens (none in last 12 months).
• · Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing).
• · Adequate clinical, ongoing support from own treating psychiatrist and other mental health clinicians, including safety plan in the event of becoming acutely suicidal, as determined by the study psychiatrist.