Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer
This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 14, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alan Davis
- Interventions being studied
- Procedure: Biospecimen Collection; Other: Counseling; Other: Interview; Drug: Psilocybin; Other: Survey Administration
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Individuals diagnosed with NSCLC, confirmed by pathology report
- Have a Karnofsky performance status \>= 60
- Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical
- outlined below
- Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression \[GRID-HAMD\] \> 16)
- English-speaking
- Over the age of 18
- Have given written informed consent
- Able to read
- Be judged by study team clinicians to be at low risk for suicidality, as defined by a score of =\< 2 on the Columbia- Suicide Severity rating scale (C-SSRS) ideation subscale, 0 on the behavior subscale, and by overall clinical judgment; and
- Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 14, 2026. Always confirm current availability with the study team.