The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD.

The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm. MDD is defined as those who meet DSM 5 diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the ICD-10.

Status Active, not recruiting
Results Published
Start date 01 September 2020
End date 01 October 2023
Chance of happening 100%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 30
Sex All
Age 18- 99
Therapy No

Trial Details

Recent randomized, placebo-controlled clinical trials of psilocybin therapy for anxiety and depression associated with cancer diagnosis showed significant improvement in study endpoints reflecting psychological distress, as compared to placebo. The effects of a single psilocybin therapy session endured for up to six months with no specific follow-up care. In this study, we aim to explore the safety and efficacy of psilocybin therapy in cancer patients, diagnosed with Major Depressive Disorder (MDD).

NCT Number NCT04593563

Sponsors & Collaborators

Maryland Oncology Hematology
This company doesn't have a full profile yet, it is linked to a clinical trial.


Acceptability of psilocybin-assisted group therapy in patients with cancer and major depressive disorder: Qualitative analysis
This interview study (n=28) explored the acceptability of psilocybin-assisted group therapy in patients with cancer and depression (MDD) who were part of a clinical trial. Through semi-structured interviews, it found a generally positive view towards group therapy, highlighting its role in enhancing participants' safety, preparedness, connection, and belonging. The study identified key factors influencing acceptability, including the therapeutic framework's importance, the complementary nature of individual sessions, and the impact of group size and interaction structure.

Psilocybin-assisted group therapy in patients with cancer diagnosed with a major depressive disorder
This Phase II, open-label trial (n=30) assessed psilocybin-assisted therapy (25mg) for patients with cancer and depression (MDD) with individual and group therapeutic support. The study reported no serious adverse events and suggested efficacy with a significant reduction in depression severity by week 8. Notably, 80% of participants had a sustained response, and 50% achieved full remission of depressive symptoms at week 1, maintained for eight weeks. The study highlights the safety and feasibility of psilocybin-assisted therapy in a group cohort.

Psilocybin-assisted therapy mediates psycho-social-spiritual change in cancer patients as assessed by the NIH-HEALS
This pre-print open-label trial (n=30) assessed psycho-spiritual change in cancer patients with major depressive disorder after a single dose of psilocybin (25mg). Participants underwent individual and group preparation and integration sessions, while the NIH-HEALS was used to assess psycho-spiritual change. Across all three factors (Connection, Reflection and Introspection) of the NIH-HEALS, psilocybin led to positive changes at all time points.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Quick Inventory of Depressive Symptomatology
The Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.

5-Dimensional Altered States of Consciousness Questionnaire
The 5D-ASC scale measures altered states of consciousness and contains 94 items (visual analog scales).

Data attribution

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