OncoMatch/Clinical Trials/NCT06319378
Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Is NCT06319378 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including psilocybin 25 mg sod and psilocybin 1 mg sod for mdd.
Treatment: psilocybin 25 mg sod · psilocybin 1 mg sod — The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is: The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9) ≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).
Check if I qualifyExtracted eligibility criteria
Performance status
WHO/ECOG 0–2
Lab requirements
Liver function
Have moderate to severe hepatic impairment, as indexed by a Child-Pugh score ≥ 7 [excluded]
Cardiac function
Have any of the following cardiovascular conditions: congenital long QT syndrome (prior diagnosis), disabling coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, clinically significant ECG abnormality (e.g., atrial fibrillation), artificial heart valve, or any other significant current or history of cardiovascular condition, based on the clinical judgment of study physician, that would make a participant unsuitable for the study
Have any of the following cardiovascular conditions: congenital long QT syndrome (prior diagnosis), any of the following if disabling physical exercise similar to walking two stairs without pause: coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, a clinically significant Screening Electro Cardio-Graphy (ECG) abnormality (e.g., atrial fibrillation); artificial heart valve; or any other significant current or history of cardiovascular condition, based on the clinical judgment of study physician, that would make a participant unsuitable for the study; Have moderate to severe hepatic impairment, as indexed by a Child-Pugh score ≥ 7
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify