Clinical TrialMajor Depressive Disorder (MDD)PsilocybinUnknown status

The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

Phase II, single-center, fixed-dose, open-label study (n=30) testing a single 25 mg oral dose of psilocybin in adults with MDD and a malignant neoplasm to assess safety, tolerability and preliminary efficacy.

Target Enrollment
30 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Single-group Phase II study administering one 25 mg oral psilocybin session with supportive conditions to adults with Major Depressive Disorder and a malignant neoplasm.

Primary outcomes focus on safety and tolerability; depressive symptoms (HAM-D17) and other psychological measures assessed at baseline and follow-ups to explore efficacy signals.

Participants must be antidepressant-free, meet DSM-5 criteria for MDD, have HAM-D17 ≥18, and have an ICD-10 C00–C97 cancer diagnosis; key exclusions include psychosis, bipolar disorder, recent psychedelic use, significant suicide risk, or uncontrolled medical illness.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin 25mg

experimental

Single 25 mg oral dose with supportive conditions.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    5 × 5 mg capsules (single session)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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 constitute a risk for an individual who is exposed 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 physical functioning.

Study Details

Locations

Maryland Oncology Hematology PA — Rockville, Maryland, United States

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