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Prof. Dr. Gerhard Gründer

Gründer G. BMBF - Bundesministerium für Bildung und Forschung 01EN2006A: EPIsoDE - Efficacy and Safety of Psilocybin in Treatment-Resistant Depression. 03/2021-02/2024.

In addition to research from the 1950s and 60s, recent modern clinical studies suggest the efficacy and safety of psilocybin, a classical psychedelic, in the treatment of depression and other psychiatric diseases. While these early results are promising, most of these studies have methodological weaknesses and shortcomings (e.g. small sample sizes), underlining the need for additional research. The proposed bicentric parallel-group study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in major depression in a controlled, randomized, double-blind design. Only such a study allows for firm conclusions on its efficacy, paving the way for future phase III studies. In order to ensure an appropriate control condition, the trial will investigate the efficacy of a therapeutic/high oral dose of psilocybin (25 mg) versus a low/supposedly inactive control dose (5 mg) versus 100 mg nicotinamide. We expect significant and stable treatment responses (defined as a ≥ 50% drop in the Hamilton Rating Scale for Depression; HAM-D) after the therapeutic (25 mg psilocybin) oral dose of psilocybin in comparison to active placebo (100 mg nicotinamide) and the low dose (5 mg psilocybin), while provoking only mild and transient adverse events (AE). The primary aim of the study is to examine the superiority of the 25 mg psilocybin over 5 mg and the placebo condition six weeks after the first dose. In a second step, the timing of treatment response/remission, the relative (%) change from baseline in terms of the initial value on the HAM-D scale and the question whether a second therapeutic dose (25 mg) is superior to only one therapeutic dose will be investigated.


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