Actively Recruiting
Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer
Led by Alan Davis · Updated on 2026-05-14
10
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with non-small cell lung cancer confirmed by pathology report
- Karnofsky performance status of 60 or higher
- Receiving chemotherapy, radiation, or biologic therapies if tolerating treatment and able to take oral psilocybin
- Moderate to severe depression symptoms (GRID-HAMD score greater than 16)
- English-speaking
- Age 18 or older
- Provided written informed consent
- Able to read
- Judged to be at low risk for suicidality by clinical assessment
- Limited lifetime use of hallucinogens (preferably no use in past 5 years; total use less than 10 times)
You will not qualify if you...
- Pregnant, nursing, or of child-bearing potential and sexually active without effective birth control
- Partners of child-bearing potential who are sexually active without effective contraception
- Recent history of coronary artery disease, stroke, uncontrolled angina or hypertension, significant ECG abnormalities, artificial heart valve, or recent transient ischemic attack
- Systolic blood pressure over 139 mm Hg, diastolic blood pressure over 89 mm Hg, or heart rate over 90 bpm
- Insulin-dependent diabetes or non-insulin dependent diabetes with recent symptomatic hypoglycemia
- Significant central nervous system issues such as unstable brain tumors, unstable seizures, cerebral aneurysm requiring intervention, dementia, or delirium
- Abnormal and clinically significant physical exam, vital signs, ECG, or lab results posing safety risk
- Any acute medical condition posing significant risk or interfering with study procedures
- Currently receiving treatment with an investigational agent
- Regular use of psychoactive medications other than prescribed SSRIs, SNRIs, or low-dose bupropion
- Positive urine test or self-report of illicit psychoactive drug use or impaired mental status
- Current or past schizophrenia spectrum or psychotic disorders, bipolar I or II disorder
- Recent moderate or severe alcohol or drug use disorder within one year
- First or second-degree relative with schizophrenia spectrum or psychotic disorders or bipolar I or II disorder
- Psychiatric conditions preventing therapeutic rapport
- History of medically significant suicide attempt as judged by study team and principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
O
Ohio State University Comprehensive Cancer Center
CONTACT
M
Michelle Pham, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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