RecruitingDepression, AnxietyPsilocybin-Assisted PsychotherapyAdvanced Cancer
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Eligible age
25+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 1. Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high
- ✓ 2. Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)
- ✓ 3. No prior grade 3 AEs on current standard of care cancer treatment regimen;
- ✓ 4. Age ≥ 25 years; as by the age of 25 brain is fully developed.
- ✓ 5. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM, by a board certified psychiatrist), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder; Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis are determined by a MD Anderson board certified psychiatrist.
- ✓ 6. At least 6 months life expectancy as per primary medical oncologist.
- ✓ 7. Have an ECOG performance status of 0, 1, or 2.
- ✓ 8. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).
You may not qualify if…
- ✕ 1. History of depression prior to cancer diagnosis.
- ✕ 2. Clinically significant suicidality or high risk of completed suicide defined as:
- ✕ i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
- ✕ 3. History of bipolar disorder, psychosis (of any nature), and seizures.
- ✕ 4. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.
- ✕ 5. ECG with QTc \> 450.
- ✕ 6. Patients with metal implants.
- ✕ 7. Asymptomatic ALT or AST elevations \>/= 5X upper limit of normal, symptomatic ALT or AST elevations \>/= 2X upper limit of normal, or total bilirubin \>/= 2X upper limit of normal.
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT06200155 · last updated 2026-06-24