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Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ)
EU CTIS ID: 2024-512911-34-00
What this study is testing
To evaluate the efficacy of a single administration of the combination of psilocybin 25 mg + trazodone 30 mg (compared to placebo), administered with psychotherapeutic support in adult patients with TRD, in improving symptoms of depression at 1 month.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.