2024-519844-34-03RecruitingPhase 2
Psilocybin versus Personalized Neuromodulation for Resistant Depression (PSILO-MODULATION)
Advancing PRecise Interventions for resistant DEpression: rebalancing brain networks and investigating the trajectories of antidepressant effect with psilocybin and personalized neuromodulation (PRIDE)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Nov 2025
Brief summary (registry, in English)
Compare the effectiveness of psilocybin and personalized rTMS in Treatment Resistant Depression (TRD)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 19 Jan 2026
- Lead sponsor
- Universita' Degli Studi G. D'Annunzio Di Chieti
- Diseases
- Depression
- EU CT number
- 2024-519844-34-03
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 68
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with depression that has not improved after at least two antidepressant medicines. It compares psilocybin with personalized rTMS brain stimulation.
- Age
- 18 to 64 years. The criteria text says 18 to 65 years.
- Sex
- All sexes can join.
- Disease stage
- Treatment-resistant depression: a diagnosis of major depressive disorder (MDD) with no response to at least two antidepressant medicines.
- Earlier treatment
- People must have taken at least two antidepressant medicines at adequate doses for adequate time (4-6 weeks) without response.
Main reasons for not taking part
- Severe organic or neurological illness
- Previous seizures
- Substance use disorders
- Cognitive decline
- Psychotic disorders
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous episodes of seizures
Other illness
- Substance use disorders
- Psychotic disorders
Other
- Presence of severe organic/neurological comorbidities
- Cognitive decline
- Pregnancy/postpartum state
Who the study is looking for
- Age between 18 and 65 years
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universita' Degli Studi G. D'Annunzio Di Chieti | Chieti Scalo | Italy | Recruiting |
| ASL Roma 5 | Colleferro (RM) | Italy | Recruiting |
| Azienda Ospedaliero Universitaria - Policlinico Riuniti Foggia | Foggia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.