NCT07490353 Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects
| NCT ID | NCT07490353 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Medical University of Vienna |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 85 participants in total. It began in 2025-11-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Participants will: * Take 25 mg of psilocybin p.o. in two sessions, in one of the two sessions they will take 1 mg risperidone p.o. before ingestion of psilocybin, to block psilocybin's acute psychedelic effects. * Undergo 3 MRI sessions, one before the first psilocybin session ('baseline') and one session each on the day after each respective psilocybin session. * Perform a variety of tasks during each fMRI session to asses the treatment's effects on anhedonia.
Eligibility Criteria
Inclusion criteria: All participants: * General health based on medical history, physical examination, blood draw, and electrocardiogram * Age 18 to 55 years * Right-handedness (due to potential lateralization effects of left-handed subjects) * Willingness and competence to sign the informed consent form * Normal BMI weight range (18.5-24.9) Specific to healthy subjects: * Psychiatric health based on structured clinical interview for DSM-5 (SCID) * No concomitant medication Specific to anhedonia patients: * Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 (SCID) and ICD-10 * Fulfilling the ICD-10 diagnostic criterion of anhedonia * No concomitant medication, specifically also free of antidepressants or other psychopharmaceuticals (for at least 2 weeks, 5 weeks for fluoxetin) Exclusion criteria: All participants: * Current or history of neurological disease * Current medical illness requiring treatment * Pregnancy or current breastfeeding * Current or former substance dependency * Any contraindication for MRI * Failure to comply with the study protocol or to follow the instruction of the investigating team * Failure to confirm effective use of contraception in females at least 8 weeks before and after study participation each * First-degree relative with bipolar disorder or schizophrenia Specific to healthy subjects: \- Psychiatric diagnosis Specific to anhedonia patients: \- Psychiatric comorbidities excluding anxiety disorders and/or obsessive-compulsive disorders
Contact & Investigator
Marie Spies, Priv.-Doz. DDr.
PRINCIPAL INVESTIGATOR
Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Frequently Asked Questions
Who can join the NCT07490353 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07490353 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07490353 currently recruiting?
Yes, NCT07490353 is actively recruiting participants. Contact the research team at marie.spies@meduniwien.ac.at for enrollment information.
Where is the NCT07490353 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07490353 clinical trial?
NCT07490353 is sponsored by Medical University of Vienna. The principal investigator is Marie Spies, Priv.-Doz. DDr. at Medical University of Vienna, Department of Psychiatry and Psychotherapy, Division of General Psychiatry. The trial plans to enroll 85 participants.
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