Psilocybin for Depression in Adults with Cancer

(2Dose Trial)

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunstone Medical

Must not be taking: Antidepressants, Antipsychotics, Cannabis, others

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of psilocybin, a compound found in magic mushrooms, to determine its potential to help people with depression who also have cancer. Participants will receive either a psilocybin capsule or a placebo. Those who do not feel better after the first dose may receive a second one. The trial aims to assess the safety and effectiveness of psilocybin for treating depression. It seeks adults with both major depressive disorder and cancer who are not currently taking antidepressants. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking any antidepressant, antipsychotic medications, or medical cannabis at the start of the study. If you are on these medications, you would need to stop them before participating.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin has been tested for safety in people with cancer and depression. In one study, psilocybin treatment proved safe and initially effective for these patients, indicating that they handled the treatment well without serious safety issues. Another study found that a single 25 mg dose of psilocybin lowered depression scores more than a smaller dose. This study also reported no major safety problems, though known risks exist. Some individuals might experience unsettling or difficult psychological effects, such as increased anxiety or symptoms of losing touch with reality. Overall, the research suggests that psilocybin can be safe for people with cancer and depression, but potential mental health side effects should be considered. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Psilocybin is unique because it represents a novel approach to treating depression in adults with cancer by using a psychedelic compound derived from certain mushrooms. Unlike traditional antidepressants, which often take weeks to become effective and are primarily SSRIs or SNRIs, psilocybin has the potential to produce rapid antidepressant effects, sometimes noticeable within just a few sessions. Researchers are excited about psilocybin because it works on the brain's serotonin receptors in a way that might foster new perspectives and relief from depressive symptoms, potentially offering a faster and more profound impact compared to conventional treatments.

What evidence suggests that psilocybin might be an effective treatment for depression in adults with cancer?

Research has shown that psilocybin, a substance found in certain mushrooms, can greatly reduce symptoms of depression. In one study, a single 25 mg dose of psilocybin led to a significant drop in depression levels over three weeks. Another study found that psilocybin helped reduce depression in cancer patients. This trial will compare psilocybin to a placebo to evaluate its effectiveness in managing depression in adults with cancer. These studies suggest that psilocybin might be useful for managing depression, especially for those who haven't improved with other treatments. Additionally, psilocybin has been linked to longer-lasting relief from depression symptoms. Overall, the evidence supports its potential as an effective treatment for depression. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with both Major Depressive Disorder (MDD) and cancer, who are not on antidepressants or antipsychotics, can join this trial. They must have a depression score of ≥20 and be able to consent. Pregnant women, those with recent drug abuse or certain medical conditions like heart issues or uncontrolled diabetes cannot participate.

Inclusion Criteria

Signed informed consent form (ICF)

I have been diagnosed with cancer.

I have been diagnosed with major depression for at least 3 months.

Exclusion Criteria

I am not taking any medications that affect my heart's rhythm.

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

A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dosing Session 1

Participants receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session

1 day

1 visit (in-person)

Dosing Session 2

Eligible participants receive psilocybin 25 mg in an open-label group session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests if two doses of psilocybin (25 mg each) help adults with MDD and cancer feel better compared to a placebo. The first dose is given in a controlled setting; patients who don't improve may receive another dose openly later.

How Is the Trial Designed?

Group I: Psilocybin Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

Sunstone Medical

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

The HOPE trial, involving 12 cancer patients, showed that psilocybin-assisted group therapy is safe, with no serious adverse events reported, and resulted in significant reductions in depression symptoms over six months.

Participants experienced substantial decreases in depression scores, with six out of twelve achieving remission at two weeks, indicating that this group therapy model could be an effective treatment for depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. Lewis, BR., Garland, EL., Byrne, K., et al.[2023]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

Psilocybin has shown significant therapeutic effects in reducing symptoms of depression and anxiety in patients with life-threatening diseases, based on a systematic review and meta-analysis of clinical trials involving 92 patients.

The results indicate that psilocybin may be a safe and effective treatment option, particularly for cases resistant to conventional therapies, with significant improvements measured by the Beck Depression Inventory and State-Trait Anxiety Inventory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. Vargas, AS., Luís, Â., Barroso, M., et al.[2020]

Psilocybin has shown promise in clinical trials for reducing symptoms of depression, indicating its potential as a novel treatment option.

Patients with treatment-resistant depression (TRD) may benefit the most from psilocybin therapy, although the risks associated with its use are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing potential of psilocybin for depressive disorders. Kozak, Z., Johnson, MW., Aaronson, ST.[2023]

In a double-blind, placebo-controlled trial with 29 cancer patients, a single dose of psilocybin (0.3 mg/kg) combined with psychotherapy led to significant and lasting reductions in anxiety and depression, with 60-80% of participants showing sustained improvements at a 6.5-month follow-up.

The positive effects of psilocybin were linked to the mystical experiences it induced, which helped improve patients' quality of life, reduce existential distress, and foster better attitudes towards death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Ross, S., Bossis, A., Guss, J., et al.[2022]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

In a randomized clinical trial involving 27 adults with major depressive disorder (MDD), psilocybin therapy combined with psychological support led to significant reductions in depression severity, with large effect sizes observed at weeks 1 and 4 after treatment.

71% of participants showed a clinically significant response to psilocybin therapy within a week, and over half achieved remission, indicating that psilocybin could be an effective treatment option for MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. Davis, AK., Barrett, FS., May, DG., et al.[2022]

A systematic review of 7 studies involving 136 participants found that psilocybin has a significant antidepressant effect, particularly at higher doses (30-35 mg/70 kg), with a Hedges' g of 3.059 indicating strong efficacy.

The study suggests that psilocybin can effectively reduce depressive symptoms in both major depression and depressed cancer patients, but further clinical trials are needed to confirm these findings and optimize dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose effect of psilocybin on primary and secondary depression: a preliminary systematic review and meta-analysis. Li, NX., Hu, YR., Chen, WN., et al.[2022]

Medicinal mushrooms like Shiitake, Turkey Tail, and Scaly Wood show promise in cancer treatment by potentially preventing lymph node metastasis, prolonging survival, and reducing side effects from chemotherapy, based on a review of nine studies.

The review highlights the need for more rigorous research, including randomized controlled trials with larger sample sizes, to confirm these benefits and determine the most effective dosages for patients with high-mortality cancers such as gastric, breast, and colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. Dan, A., Swain, R., Belonce, S., et al.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2803623

Assessment of Psilocybin Therapy for Patients With Cancer ... About 15% of patients with cancer experience major depression, which is associated with lower treatment adherence and reduced quality of ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206443

Single-Dose Psilocybin for a Treatment-Resistant Episode ... Psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10811389/

Psilocybin, an Effective Treatment for Major Depressive ... It was found that every study significantly favoured the use of psilocybin in reducing depressive symptoms, with few side effects.

4. ir.compasspathways.com ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Publication-of-Results-from-COMP004-Study-on-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx

Compass Pathways Announces Publication of Results from ... The COMP004 study's findings suggest that over a 52-week period, a single administration of 25 mg COMP360 psilocybin demonstrated a longer maintenance of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12226623/

Psilocybin therapy for treatment resistant depression MADRS score change at week 3 was the primary outcome of the study though a large reduction in depressive symptoms was evident on the day following psilocybin ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10102915/

Assessment of Psilocybin Therapy for Patients With Cancer ... Nonetheless, this study demonstrates the safety and preliminary efficacy of psilocybin treatment for patients with cancer and depression using a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500450X

a consensus statement from the US National Network of ... Long acknowledged risks include the possibility of distressing or psychologically challenging experiences, heightened anxiety, or emergence of psychotic ...

8. jpsmjournal.com jpsmjournal.com/article/S0885-3924(23)00530-4/fulltext

A Pilot Study of Psilocybin Enhanced Group Psychotherapy ... This pilot study demonstrated the safety, feasibility, and possible efficacy of psilocybin-assisted group therapy for cancer patients dealing with depressive ...