2025-521690-14-00Not yet recruitingPhase 2
Antidepressant effects of psilocybin without the psychedelic serotonin experience: A dimensional approach using functional neuroimaging.
Antidepressant effects of psilocybin in the absence of serotoninergic psychedelic experience: a dimensional functional neuroimaging approach
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- 1 Jan 2026
- Lead sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Diseases
- Depression
- EU CT number
- 2025-521690-14-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depression without psychosis, who still have a current depressive episode after at least one earlier antidepressant did not work well enough.
- Age
- 18 to 65 years
- Sex
- Men and women
- Disease stage
- Non-psychotic major depressive disorder (DSM-5) with a current major depressive episode and a score of 14 or more on the 24-HDRS
- Earlier treatment
- At least one earlier adequate antidepressant attempt that did not work. No electroconvulsive therapy, esketamine or experimental medicines or interventions in the last month. No lifetime use of serotonergic psychedelic drugs.
Main reasons for not taking part
- Another severe mental disorder or substance use disorder (nicotine dependence is allowed)
- Pregnancy or breastfeeding
- Heart rhythm problems or long QTc on the heart test
- Active suicidal thoughts
- A first-degree relative with a psychotic disorder
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.