Treatment-Resistant Depression
Conditions
Brief summary
Safety and tolerability of trazodone administered prior to psilocybin, evaluated through: -Incidence, severity, and relationship of treatment-emergent adverse events from dosing through Day 30. -Occurrence of dose-limiting toxicities within 24 hours after psilocybin-trazodone co/administration. - Clinically significant changes in vital signs, ECG, and laboratory parameters. -Emergence or worsening of suicidal ideation or behavior assessed using the Columbia–Suicide Severity Rating Scale (C-SSRS)
Detailed description
Exploratory assessment of psilocybin-induced subjective effects and preliminary attenuation-related signals, assessed using validated psychometric questionnaires, including the 5D-ASC and EBI. These endpoints will be interpreted as descriptive and hypothesis-generating only., Pharmacokinetic characterization of psilocybin, psilocin, trazodone, and mCPP following co-administration., Identification of a candidate trazodone dose/formulation for further controlled evaluation, based on the integrated assessment of safety, tolerability, PK data, and exploratory subjective pharmacodynamic outcomes.
Interventions
Sponsors
Universita' Degli Studi G. D'Annunzio Di Chieti
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of trazodone administered prior to psilocybin, evaluated through: -Incidence, severity, and relationship of treatment-emergent adverse events from dosing through Day 30. -Occurrence of dose-limiting toxicities within 24 hours after psilocybin-trazodone co/administration. - Clinically significant changes in vital signs, ECG, and laboratory parameters. -Emergence or worsening of suicidal ideation or behavior assessed using the Columbia–Suicide Severity Rating Scale (C-SSRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory assessment of psilocybin-induced subjective effects and preliminary attenuation-related signals, assessed using validated psychometric questionnaires, including the 5D-ASC and EBI. These endpoints will be interpreted as descriptive and hypothesis-generating only., Pharmacokinetic characterization of psilocybin, psilocin, trazodone, and mCPP following co-administration., Identification of a candidate trazodone dose/formulation for further controlled evaluation, based on the integrated assessment of safety, tolerability, PK data, and exploratory subjective pharmacodynamic outcomes. | — |
Outcome results
None listed