NCT07210112View on ClinicalTrials.gov

Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

October 8, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

June 30, 2030

Conditions
Depression - Major Depressive DisorderTreatment-resistant Depression (TRD)
Interventions
DRUG

Psilocybin 25 mg per os

Caps of psilocybin administered orally once (V3) under medical and psychologist supervision in group 1, 2, and 3 and in an open-label setting for group 4

DRUG

Trazodone 5mg

Oral preparation of trazodone administered orally once (V3) with psilocybin in Group 2

DRUG

Trazodone 30 mg

Oral preparation of trazodone administered orally once (V3) with psilocybin in Groups 3 \& 4

DRUG

Placebo of psilocybin

Caps of psilocybin placebo will be administered at V3 in group 4

DRUG

Placebo of trazodone

A placebo of trazodone will be administered orally at V3 in group 1

Trial Locations (1)

75014

GHU Paris Psychiatrie and Neurosciences, Paris

All Listed Sponsors
lead

Centre Hospitalier St Anne

OTHER