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Cancer Related Major Depression Treated With a Single Dose of Psilocybin

NCT06319378 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:

The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)

≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).

Conditions

Interventions

DRUG

psilocybin 25 mg sod

psilocybin 25 mg sod

DRUG

psilocybin 1 mg sod

active placebo

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Region Örebro County

    collaborator OTHER

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • Section for Affective Disorders; Northern Stockholm Psychiatry

    lead OTHER

Principal Investigators

  • Johan Lundberg, MD PhD · Norra Stockholms Psykiatri and Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319378 on ClinicalTrials.gov