Antidepressant effects of psilocybin without the psychedelic serotonin experience: A dimensional approach using functional neuroimaging.
Key facts
- Where
- Barcelona, SpanyolországSee the site
- Phase
- 2. fázis
Where in Spanyolország
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Trial code
- EU 2025-521690-14-00
- Record updated
- 2026. július 31.
- Original description
Evaluate which changes in resting-state network functional connectivity (rsNFC) induced by psilocybin are associated with the psychedelic experience by comparing functional magnetic resonance imaging (fMRI) data from patients with major depressive disorder (MDD) treated with psilocybin + pimavanserin and those treated with psilocybin + placebo across scans 1, 2, and 3.Read full original descriptionShow less
Antidepressant effects of psilocybin in the absence of serotoninergic psychedelic experience: a dimensional functional neuroimaging approach
Evaluate which changes in resting-state network functional connectivity (rsNFC) induced by psilocybin are associated with the psychedelic experience by comparing functional magnetic resonance imaging (fMRI) data from patients with major depressive disorder (MDD) treated with psilocybin + pimavanserin and those treated with psilocybin + placebo across scans 1, 2, and 3.
Inclusion: Adults diagnosed with a non-psychotic MDD according to DSM-5 criteria and who are experiencing a current major depressive episode resistant to at least one previous adequate attempt of antidepressant treatment; Patients will be men and women aged between 18 and 65 years; Patients with a score of ≥ 14 on the 24-HDRS; Individuals who have the legal capacity to personally provide informed consent and who do so.
Exclusion: In the case of individuals capable of becoming pregnant, a) a negative pregnancy test will be required during the week prior to recruitment and again on the day of recruitment, and b) the use of two highly effective contraceptive methods, one of which must be a barrier method, throughout participation in the study; Current use of other substances (medications or drugs) that may interfere with the study products; Current or past comorbidity with another severe mental disorder or substance use disorder, except for nicotine dependence; Clinically relevant impairment of renal or hepatic function; A first-degree relative with a history of any psychotic disorder; Current or past presence of serious medical conditions that pose a health risk or that interfere, either directly or due to their treatment, with the interpretation of the study; History of electroconvulsive therapy, esketamine, or experimental medications or interventions in the last month, along with lifetime use of serotonergic psychedelic drugs; Subjects with a history of rhythm disorders or other cardiac conditions, with baseline QTc values >450 ms (men) or >470 ms (women), or with electrolyte abnormalities of any cause; Subjects who are taking concomitant medications during the study with a known risk of QTc prolongation (e.g., macrolides, fluoroquinolones, antipsychotics, ondansetron, droperidol, amiodarone, sotalol, quinidine, or others); any concomitant medication taken by the subjects will be verified for this purpose by consulting the corresponding Summary of Product Characteristics (SmPC); Contraindication for psilocybin or pimavanserin; Contraindication for magnetic resonance imaging (MRI); Pregnancy or breastfeeding; Anticipated lack of availability to attend all study visits and procedures; Active suicidal ideation.