Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPlaceboRecruiting

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

This Phase II, single-center trial (n=56) investigates the efficacy, safety, and tolerability of up to two doses of psilocybin (25mg) administered at an interval of 9 to 10 weeks in patients with Major Depressive Disorder (MDD) and cancer.

Target Enrollment
56 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple-blind, placebo-controlled Phase II study using group dosing sessions to evaluate fixed 25 mg oral psilocybin versus niacin 100 mg in adults with MDD and a malignant neoplasm.

Dosing Session 1 is randomized (psilocybin 25 mg or niacin 100 mg). Non-remitters (MADRS ≥10 at V7) may roll over into an open-label Session 2 to receive a second 25 mg psilocybin dose; participants are supported by a dedicated study therapist during group sessions.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin 25 mg

experimental

Fixed 25 mg oral psilocybin, group session; open-label second dose for non-remitters.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 2 doses total

    25 mg fixed dose; second open-label 25 mg at 9–10 weeks if MADRS ≥10 (non-remitter). Group sessions with therapist support.

Niacin 100 mg

inactive

Active placebo (niacin 100 mg) given in group session during randomized portion.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Niacin 100 mg active placebo given in Dosing Session 1.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Signed informed consent form (ICF)
  • 2. 18 years of age or above at Screening (V1)
  • 3. Currently meet criteria for MDD (single or recurrent episode as defined by the DSM-5; if single episode, duration of ≥ 3 months) based on medical records, clinical assessment, and documented completion of the Mini International Neuropsychiatric Interview, version 7.0.2 (MINI 7.0.2)
  • 4. A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the ICD-10
  • 5. MADRS score ≥ 20 at Screening (V1)
  • 6. Is 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 per judgement of the Investigator

Exclusion Criteria

  • 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 the DSM-5 (MINI 7.0.2) at Screening (V1)
  • 3. Significant suicide risk 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 participant interview
  • 4. Other personal circumstances or behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin
  • 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. A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms at screening
  • 8. A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
  • 9. The use of concomitant medications that prolong the QT/QTc interval
  • 10. Uncontrolled or insulin-dependent diabetes
  • 11. Seizure disorder
  • 12. 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
  • 13. Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening (V1)
  • 14. 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 a value of < 50,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, and creatine two times above the normal range. Clinically significant abnormal electrolytes or low hemoglobin (< 8 g/L) should be corrected and rechecked prior to enrollment
  • 15. 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 they take part in the study
  • 16. Use of psychedelics, including psilocybin but excluding medical marijuana, within the past 6 months and use of psychedelics or cannabis during the current episode of depression
  • 17. Concurrent or recent chemotherapy or radiation therapy that impairs general level of physical functioning

Study Details

Locations

Sunstone Medical, PC — Rockville, Maryland, United States

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