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NCT07216404 · ClinicalTrials.gov registry record · Phase 2
Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer
A Phase 2 study of Lung Non-Small Cell Carcinoma and Unipolar Depression, sponsored by Alan Davis.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07216404: Recruiting Phase 2 study of Lung Non-Small Cell Carcinoma and Unipolar Depression, sponsored by Alan Davis.
NCT07216404 is a Phase 2 study of Lung Non-Small Cell Carcinoma and Unipolar Depression that is actively recruiting participants, run by Alan Davis. The registered enrollment target is 10 participants, below the 160-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07216404, a Phase 2 study of Lung Non-Small Cell Carcinoma and Unipolar Depression, is actively recruiting participants, sponsored by Alan Davis.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Ratings of suicidal ideation on the C-SSRS will be summarized with means and standard deviations (SD) at baseline, one day post-drug session, and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of suicidal ideation from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to det
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Survey Administration
- DRUG Psilocybin
- OTHER Interview
- OTHER Counseling
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT07216404 shows while recruiting
NCT07216404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 160-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07216404 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07216404 about?
NCT07216404 is a clinical study titled "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 comb...
What is the current status of trial NCT07216404?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2026-03-01. Estimated completion is 2026-12-31.
What conditions does trial NCT07216404 study?
This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Unipolar Depression.
What interventions are being tested in trial NCT07216404?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Survey Administration (OTHER), Psilocybin (DRUG), Interview (OTHER), Counseling (OTHER).
Who is sponsoring clinical trial NCT07216404?
This trial is sponsored by Alan Davis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07216404 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07216404's enrollment target sits among peer trials
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