PSILOCYBINE for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients will be men and women aged between 18 and 65 years."}
• {"criterion_text":"- Patients with a score of ≥ 14 on the 24-HDRS."}
• {"criterion_text":"- Individuals who have the legal capacity to personally provide informed consent and who do so."}

Exclusion criteria

• {"criterion_text":"- Current or past comorbidity with another severe mental disorder or substance use disorder, except for nicotine dependence."}
• {"criterion_text":"- Contraindication for psilocybin or pimavanserin."}
• {"criterion_text":"- Contraindication for magnetic resonance imaging (MRI)."}
• {"criterion_text":"- Pregnancy or breastfeeding."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Clinically relevant impairment of renal or hepatic function."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Anticipated lack of availability to attend all study visits and procedures."}
• {"criterion_text":"- Active suicidal ideation."}
• {"criterion_text":"- A first-degree relative with a history of any psychotic disorder."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- History of electroconvulsive therapy, esketamine, or experimental medications or interventions in the last month, along with lifetime use of serotonergic psychedelic drugs."}
• {"criterion_text":"- Current use of other substances (medications or drugs) that may interfere with the study products."}

Primary endpoints

• {"endpoint_text":"- Brain connectivity assessments using MRI: A resting-state functional sequence. A T1-weighted anatomical sequence. Using a brain rsNFC study model, beta measurement values will be obtained from the images. Statistically significant changes in these beta measures will be considered relevant to the study results.","definition_or_measurement_approach":"Resting-state functional MRI sequence and a T1-weighted anatomical sequence will be acquired. Using a brain rsNFC study model, beta measurement values will be obtained from the images; statistically significant changes in these beta measures will be considered relevant."}

Spain

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

42

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain