Phase 2 Clinical Trial to Evaluate Safety and Efficacy of Psilocybin in Cancer Patients with Major Depressive Disorder

Phase 2 Clinical Trial to Evaluate Safety and Efficacy of Psilocybin in Cancer Patients with Major Depressive Disorder

In collaboration with COMPASS Pathways, Maryland Oncology Hematology is conducting the first clinical trial to test the safety and efficacy of psilocybin therapy for the treatment of depression in cancer patients.

30 patients will be enrolled in the study over the course of six months, with each patient receiving one 25mg dose of synthesised psilocybin administered in tandem with psychotherapist support.

Participation is open to adults with malignant cancer and a diagnosis of major depressive disorder. They cannot be using medical cannabis, antipsychotics, or antidepressants at the time of screening for the study. We understand that the participant pool will be built from patients already seeking cancer care at Maryland Oncology Hematology’s Rockville location.

Each patient will be guided through their 6-8 hour psychedelic experience with one-to-one support, then followed for a minimum of 8 weeks to evaluate any changes in their mental health.

The study employs COMPASS Pathway’s COMP360 psilocybin therapy model, i.e. the co-administering of COMP360 (psilocybin) and 1:1 therapist support. COMPASS has provided support – both financially and in terms of training and advice – to the study.

The synthetic psilocybin itself is sourced from the United Kingdom, produced by Catalent Pharma Solutions.

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The Aquilino Cancer Center in Rockville, Maryland.

The study is sponsored by Maryland Oncology Hematology, PA: an independent cancer physician practice based in the eponymous US state. The clinical trial will take place Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center, a partner of COMPASS Pathways.

Due to the importance of set and setting, the therapy will take place in a specially designed 2,700 square foot centre. COMPASS Pathways assisted with the design of this space, geared toward psilocybin therapy, at Maryland Oncology Hematology’s Rockville location.

In terms of funding, COMPASS Pathways is providing financial backing for the research.

Key Facts

  • Title: The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
  • Phase: 2
  • Sponsor: Maryland Oncology Hematology
  • Funding: COMPASS Pathways
  • Participants: 30
  • Dose: one 25mg dose of COMP360, taken in five 5mg capsules
  • Timeline: 6 months
  • Status at time of publication: Recruiting
  • Identifier: NCT04593563
  • Further information