RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin for Depression, Anxiety

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.

Official registry: https://clinicaltrials.gov/study/NCT06200155 · M.D. Anderson Cancer Center · enrollment listed as 48

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin, or Niacin. The registry lists allocation as randomized. 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.

They plan to enroll about 48 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Interventions: Psilocybin, Niacin

Primary outcome (registry wording): Safety and adverse events (AEs)

Who it is for (from inclusion criteria)

Ages 25 Years to any
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)
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
At least 6 months life expectancy as per primary medical oncologist
Have an how well you can do daily activities (ECOG score) 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

Who the registry excludes

History of depression prior to cancer diagnosis
Clinically significant suicidality or high risk of completed suicide defined as:
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

Public study contact (from the registry)

Moran Amit, MD

(713) 794-5304

mamit@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

MD Anderson Cancer Center — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT06200155 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06200155?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06200155?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary