Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer

NCT05947383 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: SUN003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose. In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed. In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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 International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals. The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.

Conditions

Cancer; Major Depressive Disorder

Keywords

psilocybin; cancer; depression

Outcome Measures

Primary Outcomes (1)

• The Montgomery-Asberg Depression Rating Scale (MADRS)

  The primary endpoint of efficacy (psilocybin versus active placebo) in this study will be evaluated as change from baseline in MADRS total score at V7 (Week 8).

  8 weeks

Secondary Outcomes (5)

• Treatment-emergent and serious adverse events (TEAEs and SAEs)

  8 weeks

• Electrocardiogram (ECG)

  8 weeks

• Laboratory results

  8 weeks

• Vital Signs

  8 weeks

• Columbia Suicide Severity Rating Scale (C-SSRS)

  8 weeks

Study Arms (2)

Psilocybin

EXPERIMENTAL

Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Psilocybin DRUG

Psilocybin 25 mg oral capsule

Psilocybin

Placebo DRUG

Niacin 100 mg oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form (ICF)
• years of age or above at Screening (V1)
• 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)
• A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the ICD-10
• MADRS score ≥ 20 at Screening (V1)
• Is not currently taking any antidepressant and/or antipsychotic medications or medical cannabis at Screening (V1)
• Able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
• Has capacity to consent per judgement of the Investigator

You may not qualify if:

• 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)
• Current (within the past year) alcohol or drug use disorder as defined by the DSM-5 (MINI 7.0.2) at Screening (V1)
• 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
• Other personal circumstances or behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin
• 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)
• 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
• A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 450 ms at screening
• A history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
• The use of concomitant medications that prolong the QT/QTc interval
• Uncontrolled or insulin-dependent diabetes
• Seizure disorder
• 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
• Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening (V1)
• 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
• 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

Sponsors & Collaborators

• Sunstone Medical: lead

Study Sites (1)

Sunstone Medical, PC

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Neoplasms; Depressive Disorder, Major; Depression

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)