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NCT07210112: PSILOTRAZ
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
Phase 2 trial testing Psilocybin 25 mg per os in Depression - Major Depressive Disorder in 112 participants. Not yet recruiting.
31 December 2029
Quick facts
| Lead sponsor | Centre Hospitalier St Anne |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 8 October 2025 |
| Primary completion | 31 December 2029 |
| Estimated completion | 30 June 2030 |
| Sites | 1 location across France |
Drugs / interventions tested
- Psilocybin 25 mg per os — full drug profile →
- Trazodone 5mg — full drug profile →
- Trazodone 30 mg — full drug profile →
- Placebo of psilocybin — full drug profile →
- Placebo of trazodone — full drug profile →
Conditions studied
- Depression - Major Depressive Disorder — all drugs for Depression - Major Depressive Disorder →
- Treatment-resistant Depression (TRD) — all drugs for Treatment-resistant Depression (TRD) →
Sponsor
Centre Hospitalier St Anne
Who can join
18 and older, any sex, with Depression - Major Depressive Disorder or Treatment-resistant Depression (TRD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin. We hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07210112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07210112 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier St Anne
- Last refreshed: 7 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07210112.
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