RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin for Depression

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

Official registry: https://clinicaltrials.gov/study/NCT06801041 · M.D. Anderson Cancer Center · enrollment listed as 20

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. The registry lists allocation as na. This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

They plan to enroll about 20 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

Interventions: Psilocybin

Primary outcome (registry wording): Safety and Adverse Events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Subjects must have solid or hematological malignancy that does not involve the brain
Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months
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
Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance
Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin

Who the registry excludes

Clinically significant suicidality or high risk of completed suicide defined as:
History of bipolar disorder, psychosis (including a history of schizophrenia)
Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating
Postmenopausal (no menses in greater than or equal to 12 consecutive months)
History of hysterectomy or bilateral salpingo-oophorectomy
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional

Public study contact (from the registry)

Moran Amit, MD, PHD

(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

The University of Texas M. D. Anderson Cancer Center — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT06801041 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 NCT06801041?

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 NCT06801041?

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