A phase II randomized, double-blind, active placebo-controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE)

This therapeutic exploratory trial (n=144) will investigate the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP/PAT) in adults aged 25 to 65 with treatment-resistant major depressive disorder (TRMDD).

Led by Prof. Dr. med. Gerhard Gründer, the trial will be conducted at the Central Institute of Mental Health (CIMH) Mannheim and Charité Berlin, Campus Mitte. Participants must have a diagnosis of moderate to severe major depressive disorder without psychotic features and must have shown treatment resistance to two different classes of antidepressants. They must also have discontinued monoaminergic psychiatric medications for at least two weeks prior to the study.

The trial will involve two doses of psilocybin (25 mg each), administered three weeks apart, alongside psychotherapy sessions. The primary endpoint, evaluated six weeks after the first dose, is the number of treatment responders, defined as a ≥50% reduction in symptoms measured by the Hamilton Depression Scale (HAM-D). Secondary endpoints include assessing treatment response, rates of remission, safety parameters, and follow-up evaluations at six and twelve months after the first dose.

The trial is controlled, randomised, and double-blind. It has a parallel group design and three treatment arms: nicotinamide, 5 mg psilocybin, and 25 mg psilocybin.

You can find more info about the EPIsoDE trial here.

Trial Details

This trial (n=144) examines Psilocybin-Assisted Psychotherapy for adults (25-65) with treatment-resistant major depressive disorder. Led by Prof. Dr. Gerhard Gründer, it's conducted at CIMH Mannheim and Charité Berlin. Participants undergo two psilocybin doses (25 mg each) alongside psychotherapy. Primary endpoint: ≥50% symptom reduction measured by HAM-D six weeks post-first dose. Secondary endpoints include treatment response and safety evaluations. Randomised, double-blind, with three treatment arms: nicotinamide, 5 mg psilocybin, and 25 mg psilocybin.

NCT Number 2019-003984-24

Data attribution

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