Dry extract from Psilocybe cubensis (15-25:1), extraction solvent: methanol (psilocybin-containing extract) for Treatment-resistant depression

Inclusion criteria

• {"criterion_text":"- Age between 18 and 65 years"}
• {"criterion_text":"- Diagnosis of TRD: subjects with a MDD diagnosis, non-responders to at least two antidepressant medications at adequate doses administered for adequate time (i.e., 4-6 weeks)"}

Exclusion criteria

• {"criterion_text":"- Presence of severe organic/neurological comorbidities"}
• {"criterion_text":"- Previous episodes of seizures"}
• {"criterion_text":"- Substance use disorders"}
• {"criterion_text":"- Cognitive decline"}
• {"criterion_text":"- Psychotic disorders"}
• {"criterion_text":"- Pregnancy/postpartum state"}

Primary endpoints

• {"endpoint_text":"- Non-inferiority (with a 25% margin) in terms of percentage of clinical responders, defined as the reduction in Montgomery-Asberg Depression Rating Scale (MADRS) scores ≥ 50%, after 60 days from the start of the trial.","definition_or_measurement_approach":"Clinical responders defined as reduction in MADRS scores ≥ 50% at 60 days from trial start; non-inferiority margin 25% comparing percentage of responders between arms."}

Secondary endpoints

• {"endpoint_text":"- Hamilton Anxiety Rating Scale (HAM-A) score","definition_or_measurement_approach":"Measured by HAM-A total score."}
• {"endpoint_text":"- Hamilton Depression Rating Scale (HAM-D) score","definition_or_measurement_approach":"Measured by HAM-D total score."}
• {"endpoint_text":"- Brief Psychiatric Rating Scale (BPRS) score","definition_or_measurement_approach":"Measured by BPRS total score."}
• {"endpoint_text":"- Young Mania Rating Scale (YMRS) score","definition_or_measurement_approach":"Measured by YMRS total score."}
• {"endpoint_text":"- Snaith-Hamilton Pleasure Scale (SHAPS) scores for anhedonia","definition_or_measurement_approach":"Measured by SHAPS scores assessing anhedonia."}
• {"endpoint_text":"- Columbia–Suicide Severity Rating Scale and Beck Hopelessness Scale scores for suicide risk","definition_or_measurement_approach":"Measured by C-SSRS and Beck Hopelessness Scale scores assessing suicide risk and hopelessness."}
• {"endpoint_text":"- Trail Making Test for attention and executive functions","definition_or_measurement_approach":"Performance on Trail Making Test assessing attention and executive function."}
• {"endpoint_text":"- Clinical Global Impression Severity (CGIS) and Health Status Questionnaire scores for impact of symptoms on health","definition_or_measurement_approach":"Measured by CGIS score and health-status questionnaire outcomes."}
• {"endpoint_text":"- Functional magnetic resonance imaging (fMRI) analysis for changes in connectivity patterns in TRD-related brain networks","definition_or_measurement_approach":"fMRI connectivity analysis to detect changes in TRD-related brain network connectivity patterns."}
• {"endpoint_text":"- Electroencephalography (EEG) for changes in functional connectivity","definition_or_measurement_approach":"EEG analysis assessing changes in functional connectivity."}

Italy

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

08-07-2025

Processing Time Days

12

Number Of Sites

3

Number Of Participants

68

Primary sponsor

Full Name

Universita' Degli Studi G. D'Annunzio Di Chieti

Organisation Type

Educational Institution

Country Of Registered Address

Italy