Psilocybin for Treatment-Resistant Depression

This interventional trial (n=40) aims to assess the efficacy of psilocybin (25mg) with psychological support on anhedonia in individuals with treatment-resistant major depressive disorder (MDD).

Participants will be randomly assigned to either receive psilocybin or an active placebo, with both groups receiving psychological support during dosing.

The primary outcome measure will be the change from baseline in self-reported anhedonia scores on the Dimensional Anhedonia Rating Scale (DARS), assessed one week post-dosing. Secondary outcome measures include changes in depression scores, response bias for high reward conditions, and nucleus accumbens neural activation.

The study, sponsored by the University of Colorado, Denver, is set to commence from March 2024 with an estimated completion date of March 2025.

Eligible participants must be adults aged 21 or above, diagnosed with major depressive disorder, and deemed treatment-resistant. They should also meet specific inclusion criteria and agree to abstain from caffeine and nicotine before fMRI scan visits.

The trial is conducted at the University of Colorado Anschutz Medical Campus in Aurora, Colorado, United States.

Trial Details

The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.

NCT Number NCT06230757

Data attribution

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