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New treatment option for Depression, Anxiety
Official title Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
ClinicalTrials.gov ID: NCT06200155
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, being studied as a potential treatment for depression, anxiety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial...
- Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1...
- No prior grade 3 AEs on current standard of care cancer treatment regimen;
- Age ≥ 25 years; as by the age of 25 brain is fully developed.
- Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM, by a board certified psychiatrist), of one or...
You likely can't join if
- History of depression prior to cancer diagnosis.
- 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...
- History of bipolar disorder, psychosis (of any nature), and seizures.
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total...
- ECG with QTc \> 450.
- Patients with metal implants.
See the full eligibility criteria
- 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...
- 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...
- No prior grade 3 AEs on current standard of care cancer treatment regimen;
- Age ≥ 25 years; as by the age of 25 brain is fully developed.
- 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...
- At least 6 months life expectancy as per primary medical oncologist.
- Have an ECOG performance status of 0, 1, or 2.
- Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).
- Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.
- Agree to abstain from any nicotine products for at least 12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed) as well as on days of...
- Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions (except as described above for nicotine and caffeine) and must refrain from psychoactive drugs 12 hours after psilocybin...
- Must be free from any regularly scheduled psychotropic (antidepressant/anxiolytic class) medications and those with primary MOA on serotonergic neurons (e.g., ondansetron) for a minimum of 2 weeks prior to study or 4...
- Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.
- Eligible participants will have a responsible individual that will provide transportation home after the psilocybin session is complete.
- Fluent in English
- History of depression prior to cancer diagnosis.
- 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...
- History of bipolar disorder, psychosis (of any nature), and seizures.
- Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.
- ECG with QTc \> 450.
- Patients with metal implants.
- 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.
- The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate...
- persons with first- or second-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder.
- Actively progressing disease as defined by the primary oncologist.
- Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.
- Participants with brain metastases.
- Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \>140/90 mmHg and HR\> 90 bpm.
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: i...
- Significant central nervous system (CNS) pathology. Some examples include: i. Primary or secondary cerebral neoplasm ii. Epilepsy iii. History of stroke iv. Cerebral aneurysm v. Dementia vi. Delirium
- a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5...
- Participants who have any of the below niacin contraindications:
- Active liver disease or unexplained persistent elevations in hepatic transaminases
- active peptic ulcer disease
- arterial bleeding
- Hypersensitivity to niacin or any component of this medication
- BP\> 200/110 (or malignant hypertension defined as 200/120) would prevent a patient from receiving psilocybin dosing and would prompt calling a physician during blood pressure monitoring for cardiac risk evaluation.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.