Advanced Cancer / Depression, Anxiety / Niacin · Phase 2 Trial

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration at M.D. Anderson Cancer Center currently recruiting participants to assess the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and anxiety in patients with advanced cancer. No results are posted in this registry record; the study is still active and enrolling.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Supportive Care purpose. Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer; age from 25 Years. Intervention: Arm A. Compared with: Arm B — Placebo Comparator. n = 30. 1 site: United States.

Key findings

Safety

No efficacy, safety, or adverse event data available; study completion anticipated within approximately 1 year from activation.

Who this may help

Clinicians should note this trial is in active recruitment and not yet reporting efficacy or safety data. Until results are published, the role of psilocybin-assisted psychotherapy in cancer-related psychiatric symptoms remains unevaluated in this cohort.

Plain-language summary

This is an active Phase 2 trial registration with no results yet posted; it describes a planned study of feasibility and safety in a small cohort.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Safety and adverse events (AEs) (assessed at Through study completion; an average of 1 year.)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Supportive Care purpose

PopulationDepression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer; age from 25 Years

Sample size30

InterventionArm A

ComparatorArm B — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment30

PhasePhase 2

Primary outcome measureSafety and adverse events through study completion; an average of 1 year

Recruitment statusRECRUITING

Clinical bottom line

Caveats

No results are posted; this is a trial registration only.
Blinding, control arm design, and allocation methods not specified in registry record.
No efficacy, safety, or adverse event data available; study completion anticipated within approximately 1 year from activation.
Sample size is small (n=30) and appropriate for Phase 2 feasibility assessment only.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design; control arm and blinding status not specified in registry.

Directness

moderate

Clinical population with advanced cancer; primary outcomes include safety and feasibility.

Consistency

insufficient

Registry record only; no results reported, consistency cannot be assessed.

Risk of bias

insufficient

Study design details insufficient to evaluate bias; blinding and allocation concealment not stated.

Sample adequacy

limited

Estimated enrollment 30 participants; Phase 2 feasibility study, not powered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06200155). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer. Interventions: DRUG: Psilocybin; OTHER: Niacin. Primary outcome measures: Safety and adverse events (AEs) , Through study completion; an average of 1 year.. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Advanced CancerNCT06200155Depression, AnxietyM.D. Anderson Cancer CenterNiacinPsilocybin Assisted PsychotherapyPsilocybin