Psilocybin Medicine Open-Label Study (PMOS): a... — Clinical Trial Details

Open-label, non-randomised Phase II study delivering two supervised 25 mg oral psilocybin doses paired with preparatory and integration psychotherapy for participants with treatment-resistant depression.

Therapy comprises three preparatory sessions, two dosing sessions (visits 5 and 9) each followed by three integration sessions; outcomes include safety, depressive symptoms (GRID-HAMD), and AE monitoring with follow-up at 4 weeks and 6 months.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

The following inclusion criteria will be used:
1. Adults aged 18 years or older;
2. Understanding of English (with interpreter if needed) who have provided, or have capacity to provide informed consent;
3. Are capable of conforming to study related procedures;
4. Participants with a medical history of Major Depressive Disorder (SCID-5) and are currently experiencing a major depressive episode with low risk of suicidality;
5. Participants with a baseline GRID-HAMD score greater than or equal to 20, indicating moderate-severe depression;
6. 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;
7. 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;
8. 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)
9. 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;
10. 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);
11. 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;
12. 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);
13. Have minimal hallucinogen use in the past five years and a total hallucinogen use less than 10 times.

Exclusion Criteria

The following exclusion criteria will be used:
1. Evidence of significant suicide risk, including a history of medically significant suicide attempts;
2. Depression secondary to another medical condition;
3. Judged incompatible with establishment of rapport with the therapy team and/or safe exposure to psilocybin e.g., suspected borderline personality disorder;
4. Any patient with moderate-severe hepatic and/or renal dysfunction, major CNS disorders, and diagnosed with epilepsy, or has a history of seizure activity;
5. Patients with cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, prolonged QTc interval, artificial heart valve, or transient ischaemic attack in the past year;
6. Has a history of diabetic neuropathy or has presence of significant endocrine disorder;
7. If taking oral hypoglycaemic agent, then no history of hypoglycaemia;
8. Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or lactating mothers;
9. Women of child-bearing age who are not on birth control and not practising safe sex activities;
10. For individuals who have intermittent or PRN use of medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose;
11. Participants taking medications including: Rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, paclitaxol, St John's Wort, all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, or troleandomycin;
12. Patients with a history of DSM-5 eligibility criteria for moderate or severe alcohol misuse, any illicit drug or alcohol dependence syndrome, schizophrenia spectrum or other psychotic disorders (including substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder;
13. Have a history of, or a first degree relative with a history of psychosis or mania, schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar affective disorder (type I or type II); any personality disorder or dementia.
14. Had a previous psychotic episode or any other psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin.

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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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin-assisted psychotherapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details