Condition: Depression - Major Depressive Disorder · Anhedonia · Sponsor: Medical University of Vienna
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1. Systematically categorize prohedonic effects (antianhedonic effects in patients with anhedonia in depression, increase in well-being in all participants). 2. Test effects of psilocybin on brain network complexity measures during the hedonic experience using fMRI as a correlate for prohedonic (anti-anhedonic and well-being increasing) effects. 3. Elucidate relevance of the psychedelic experience to these effects (clinical, behavioral, and imaging) in a pharmacological challenge using the 5-HT2A/D2 antagonist risperidone and extensive characterization of the psychedelic experience. Secondary Objectives 4. Test the differential effects of the psychedelic experience on fMRI paradigms measuring symptoms shown to be altered in anhedonia, more specifically reward processing and sexual arousal. 5. Test the relevance of neuroplasticity (BDNF) and inflammatory parameters to anti-anhedonic, well-being promoting, and brain network dynamic complexity effects. 6. Test the effects of the psychedelic experience on BDNF and inflammatory parameters. Researchers will compare the effects of psilocybin in two separate sessions (one with psilocybin alone, one with co-administration of risperidone) in both patients with depression and anhedonia and healthy control participants. Partici…
This description comes directly from the study's public registry record.
Marie Spies, Priv.-Doz. DDr. · +43 1 40400 · marie.spies@meduniwien.ac.at
Clemens Schmidt, MD · +43 1 40400 · clemens.schmidt@meduniwien.ac.at
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| Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry | Vienna, State of Vienna, Austria | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07490353