The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
This is a Phase II, single-center, fixed dose, open label trial to explore the safety,
 tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study
 population will include adult men and women, 18 years of age or above, with MDD, diagnosed
 with a malignant neoplasm. MDD is defined as those who meet DSM 5 diagnostic criteria for a
 single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant
 neoplasm is defined as having a diagnostic code from C00 to C97 according to the ICD-10.
Recent randomized, placebo-controlled clinical trials of psilocybin therapy for anxiety and
 depression associated with cancer diagnosis showed significant improvement in study endpoints
 reflecting psychological distress, as compared to placebo. The effects of a single psilocybin
 therapy session endured for up to six months with no specific follow-up care. In this study,
 we aim to explore the safety and efficacy of psilocybin therapy in cancer patients, diagnosed
 with Major Depressive Disorder (MDD).
Inclusion Criteria:

 1. Signed ICF

 2. 18 years of age or above at Screening (V1)

 3. Currently meet criteria for MDD (single or recurrent episode as defined by DSM 5; if
 single episode, duration of more or equal to 3 months) based on medical records,
 clinical assessment and documented completion of the MINI version 7.0.2

 4. A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according
 to the International Classification of Diseases and Related Health Problems, 10th
 Revision (ICD-10)

 5. HAM D 17 score ≥18 at Screening (V1) and at Baseline (V2)

 6. Are not currently taking any antidepressant and/or antipsychotic medications, or
 medical cannabis, at Screening (V1)

 7. Able to complete all protocol required assessment tools without any assistance or
 alteration to the copyrighted assessments, and to comply with all study visits

 8. Has capacity to consent (assessed via investigator judgement)

 Exclusion Criteria:

 Psychiatric Exclusion Criteria:

 1. Current or past history of schizophrenia, psychotic disorder, bipolar disorder,
 delusional disorder, paranoid personality disorder, schizoaffective disorder, or
 borderline personality disorder, as assessed by medical history and a structured
 clinical interview (MINI version 7.0.2)

 2. Current (within the past year) alcohol or drug use disorder as defined by DSM 5 (MINI
 7.0.2) at Screening (V1)

 3. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or
 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal
 behaviors within the past year, or; (3) clinical assessment of significant suicidal
 risk during subject interview

 4. Other personal circumstances and behaviour judged to be incompatible with
 establishment of rapport or safe exposure to psilocybin

 General Medical Exclusion Criteria:

 5. Women who are pregnant, nursing, or planning a pregnancy. Women and men of child
 bearing potential and who are sexually active must agree to use an acceptable
 contraceptive method throughout their participation in the study. Women of child
 bearing potential must have a negative urine pregnancy test at Screening (V1) and
 Baseline (V2)

 6. Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent
 myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood
 pressure >140/90) or clinically significant arrhythmia within 1 year of signing the
 ICF

 7. Uncontrolled or insulin dependent diabetes

 8. Seizure disorder

 9. Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. Any
 positive urine drug test will be reviewed with participants to determine the pattern
 of use and eligibility will be determined at the investigator's discretion in
 conjunction with the medical monitor

 10. Current enrollment in any investigational drug or device study or participation in
 such within 30 days of Screening.

 11. Abnormal and clinically significant results on the physical examination, vital signs,
 ECG, or laboratory tests at Screening (V1) that in the investigator's opinion may
 consistute a risk for an individual who is explosed to psilocybin. This includes
 platelets below 50,000 platelets per cubic millimeter of blood, liver function tests
 three times the upper limit of normal, creatine two times above the normal range.
 Clinically significant abnormal electrolytes or low hemoglobin (below 8 g/L) should be
 corrected and rechecked

 12. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic,
 renal or any other major concurrent illness that, in the opinion of the investigator,
 may interfere with the interpretation of the study results or constitute a health risk
 for the participant if he/she takes part in the study

 13. Use of psychedelics, including psilocybin but excluding medical marijuana, within the
 past 12 months and use of psychedelics during the current episode of depression

 14. Concurrent or recent chemotherapy or radiation therapy, that impairs general level of
 phsyical functioning.