RecruitingPhase 2

Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer

United States10 participantsStarted 2026-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 exclusion criteria 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) Exclusion Criteria: * GENERAL MEDICAL EXCLUSION CRITERIA * Participants who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; participants who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control (i.e., implants, injectables, combined oral contraceptives, progestin containing intrauterine devices \[I…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)

Timeframe: At baseline, one day post-drug session, and 4 weeks post-drug session

Incidence of adverse events

Timeframe: At baseline, one day post-drug session, and 4 weeks post-drug session

Acceptability of psilocybin-assisted therapy

Timeframe: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

Satisfaction of psilocybin-assisted therapy

Timeframe: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

Trial details

NCT IDNCT07216404

SponsorAlan Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-31

Contact for this trial

Ohio State University Comprehensive Cancer Center

18002935066 osucccclincaltrials@osumc.edu

View on ClinicalTrials.gov More Lung Non-Small Cell Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)

Timeframe: At baseline, one day post-drug session, and 4 weeks post-drug session

Incidence of adverse events

Timeframe: At baseline, one day post-drug session, and 4 weeks post-drug session

Acceptability of psilocybin-assisted therapy

Timeframe: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session

Satisfaction of psilocybin-assisted therapy

Timeframe: At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session