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CancerPhase 22DoseNCT05947383

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

A Phase 2 study testing Psilocybin in people with Cancer and Major Depressive Disorder, run by Sunstone Medical at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Major Depressive Disorder
What is being tested?
Psilocybin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
23 Oct 2023to 1 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form (ICF)
  • 18 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • 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
  • Concurrent or recent chemotherapy or radiation therapy that impairs general level of physical functioning

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sunstone Medical, PC

    Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: A Phase 2, 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 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.

Read more

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.

Being tested
Psilocybin, Placebo
Keywords
psilocybin, cancer, depression
Medical subject headings
Neoplasms, Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    Psilocybin 25 mg oral capsule

  • PlaceboDrug

    Niacin 100 mg oral capsule

Study groups in NCT05947383
Study groupRoleWhat they receive
PsilocybinExperimentalNot described
Receives: Drug: Psilocybin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 8 weeks

Secondary outcomes (5)

  1. Treatment-emergent and serious adverse events (TEAEs and SAEs)

    Incidence and occurrence of treatment-emergent adverse events (TEAEs) and SAEs from the days of psilocybin treatment (V3 and V9) to V7 and V13 and from the day after each psilocybin treatment (V4 and V10) to V7 and V13.

    Measured: 8 weeks

  2. Electrocardiogram (ECG)

    Incidence of clinically important changes in electrocardiogram (ECG) parameters from Screening (V1) to V7 and from the day before the second psilocybin treatment (V8) to V13.

    Measured: 8 weeks

  3. Laboratory results

    Incidence of clinically important changes in laboratory results from Screening (V1) to V7 and from V8 to V13.

    Measured: 8 weeks

  4. Vital Signs

    Incidence of clinically significant changes in vital signs from Screening (V1) to V7 and from V8 to V13.

    Measured: 8 weeks

  5. Columbia Suicide Severity Rating Scale (C-SSRS)

    Incidence of changes in suicidal ideation/behavior (measured using the Columbia Suicide Severity Rating Scale [C-SSRS]) score at all visits from Baseline (the day before each Dosing Session) (V2 and V8) to V7 and V13.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start23 Oct 2023
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947383
Sponsor's protocol ID
SUN003
Acronym
2Dose
Status last verified
May 2026
First submitted
7 Jul 2023
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Cancer and Major Depressive Disorder, run by Sunstone Medical at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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