Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ)
Date de révision : 19/05/2026
112 participants
Homme Femme
A partir de 18 ans
Critères :
Critères d'inclusion :
- Age ≥ 18 years old
- Patient with major depressive episode without psychotic features according to DSM-5 criteria
- MADRS score ≥ 20
- Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ)
- Free, informed and prior written consent of the patient
- Persons covered by the social security system
Critères d'exclusion :
- Bipolar disorder
- Uncontrolled thyroid disorder
- Significant suicide risk, as defined by: (a) suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline (b) demonstrating suicidal behaviors in the past six months, or; (c) clinical assessment of significant suicidal risk or risk of self-injury during participant interview
- Epilepsy
- Contraindications to MRI: Implants (mechanical or electronic: cochlear implants, pacemakers, infusion pumps, magnetic clips, etc.) incompatible with the magnetic field; Metallic foreign bodies in the eye or nervous system; Claustrophobia; Non-removable dental removable braces
- 5-HT2A antagonist treatment (including quetiapine, olanzapine, aripiprazole)
- Lithium treatment
- Treatment with buprenorphine or opioids
- Use of psychedelics (psilocybin, lysergic acid, ayahuasca, mescaline and derivatives) during current episode
- Persons deprived of their liberty by judicial or administrative decision, persons under compulsory psychiatric care
- Persons under legal protection or unable to give consent
- Any clinical event that, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study
- Schizophrenia and psychosis
- Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD
- Parkinson’s disease treated by selegiline or levodopa
- HIV treated by ritonavir and indinavir
- Active infection treated by erythromycin
- Fungal infection treated by ketoconazole and itraconazole
- Concomitant therapies
- Legal status
- Other: Any clinical manifestation which, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study
- Personal or family history of psychotic disorder
- History of personality disorder
- Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders
- Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment
- Pregnancy and breastfeeding women
- Cardiovascular history (myocardial infarction, stroke, heart rhythm disorder, uncontrolled hypertension, QT interval prolongation, tachycardia and poor cardiovascular health)
- Uncontrolled diabetes
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