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Psilocybin

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psilocybin 25 mg sod

psilocybin 1 mg sod

Johan Lundberg

Helena Werin Sjögren, MD

Mikael Landén, MD PhD

Evana Lopez, MD

Carl-Johan Ekman, PhD

Evana Lopez

robert Bodén, MD PhD

Axel Nordenskjöld, MD PhD

axel Nordenskjöld, MD PhD

Johan Lundberg, MD PhD

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).

Randomized Controlled Trial, active placebo, randomization ratio 2:1

Cancer Related Major Depression Treated With a Single Dose of Psilocybin

CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

Montgomery Asberg Depression Rating Scale (MADRS) total score (0-60, smaller equals better)

Montgomery Asberg Depression Rating Scale self rating (MADRS-S) (0-54, smaller equals better)

Sheehan Disability Scale (SDS) (0-10, smaller equals better)

Clinical Global Impression (CGI), (1-7, smaller equals better)

Euroquol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

Assessing Quality of Life 6 dimensions (AQOL-6D) (0-99, smaller equals better)

General Anxiety Disorder 7 (GAD-7) (0-21, lower equals better)

Hospital Anxiety and Depression Scale (HADS) (0-42, smaller equals better)

Euroqol 5 Dimension scale (EQ5D-5L), 0-1, higher equals better

Spots Global Cancer Trial Database for psilocybin 25 mg sod