A phase IIa open-label dose-finding study with lead-in phase evaluating the safety, pharmacokinetics, and attenuating effects of trazodone on the consciousness-altering effects of psilocybin in individuals with Treatment-Resistant Depression
- Registry ID
- 2025-523346-27-00
- Source registry
- CTIS
- Status
- Suspended
- Phase
- PHASE2
- Study type
- INTERVENTIONAL
- Sponsor
- Universita' Degli Studi G. D'Annunzio Di Chieti
- Enrollment
- 30
- Last update
- 2026-08-14
Conditions
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Treatment-Resistant Depression
Primary outcomes
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)
Locations
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