Cancer Related Major Depression Treated With a Single Dose of Psilocybin
Status:
RECRUITING
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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).
Phase:
PHASE2
Details
Lead Sponsor:
Section for Affective Disorders; Northern Stockholm Psychiatry
Collaborators:
Karolinska Institutet Region Örebro County Uppsala University Hospital Vastra Gotaland Region