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The Acute and Long-term Impact of Support in Psilocybin Therapy for Depression: The Psilocybin Setting Trial (PSISET)
EU CTIS ID: 2025-522961-31-01
What this study is testing
To evaluate the efficacy of psilocybin with psychotherapy compared to psilocybin with basic support on depressive symptoms. To evaluate the effects of psilocybin with psychotherapy compared to standard of care on depressive symptoms.
- 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
- Informed oral and written consent.
- Meeting diagnostic criteria for moderate-severe MDD according to the International Classification of Diseases 10 (ICD-10) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- A MADRS total score between 20-60 (both included).
- Aged 18 years or above
- Being willing to abstain from other psychotherapeutic or antidepressant treatments until at least the 6-week primary endpoint.
- Have an identified support person.
You likely can't join if
- Meeting ICD-10 diagnostic criteria for mental retardation, schizophrenia spectrum, or other psychotic disorders, and bipolar disorders.
- Concomitant treatment with medication that modulates uridine diphosphate (UDP) or glucuronosyltransferase (UGT).
- Use of any serotonergic psychedelic drug within the past 10 years or > 25 lifetime uses.
- Cardiovascular disease, including a history of myocardial infarction, angina pectoris, heart failure (NYHA class ≥ III), prolonged QTc interval (>450 ms/470 ms men/women)
- Uncontrolled hypertension (systolic blood pressure >150mm Hg, diastolic blood pressure >90 mm Hg*).
- Females of childbearing potential who are pregnant, breastfeeding or have the intention of becoming pregnant within the next 12 weeks, or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device – IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
See the full eligibility criteria
Who can join
- Informed oral and written consent.
- Meeting diagnostic criteria for moderate-severe MDD according to the International Classification of Diseases 10 (ICD-10) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- A MADRS total score between 20-60 (both included).
- Aged 18 years or above
- Being willing to abstain from other psychotherapeutic or antidepressant treatments until at least the 6-week primary endpoint.
- Have an identified support person.
What rules you out
- Meeting ICD-10 diagnostic criteria for mental retardation, schizophrenia spectrum, or other psychotic disorders, and bipolar disorders.
- Concomitant treatment with medication that modulates uridine diphosphate (UDP) or glucuronosyltransferase (UGT).
- Use of any serotonergic psychedelic drug within the past 10 years or > 25 lifetime uses.
- Cardiovascular disease, including a history of myocardial infarction, angina pectoris, heart failure (NYHA class ≥ III), prolonged QTc interval (>450 ms/470 ms men/women)
- Uncontrolled hypertension (systolic blood pressure >150mm Hg, diastolic blood pressure >90 mm Hg*).
- Females of childbearing potential who are pregnant, breastfeeding or have the intention of becoming pregnant within the next 12 weeks, or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device – IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- Pregnancy (serum human chorionic gonadotropin (hCG) > 3 U/L at inclusion).
- Hypersensitivity to the active substance or any of the excipients
- Unable to speak and/or understand Danish
- Any condition that the investigator feels would interfere with trial participation.
- No psychotic symptoms of depression or the like.
- Immediate family history of psychotic disorders or bipolar disorders, including parents and siblings, but not offspring.
- Any co-morbid psychiatric condition deemed to be incompatible with the safe administration of psilocybin, e.g., inability to establish rapport.
- Meeting ICD-10 diagnostic criteria for substance use disorder and/or alcohol use disorders.
- History of suicide attempt or: 1) active suicidal ideation with some intent to act without specific plan (C-SSRS item 4), 2) active suicidal ideation with specific plan and intent (C-SSRS item 5), 3) have a score of ≥ 5 on Item 10 (suicidal thoughts) on MADRS at screening, 4) have any suicidal ideation or thoughts, in the opinion of the study personnel, PI, the support person or close relatives, that present a serious risk of suicidal or self-injurious behavior at any time.
- Present or former severe neurological disease, including epilepsy and head trauma with loss of consciousness > 30 min.
- Concomitant treatment against depressive disorder including pharmacotherapies, electroconvulsive therapy, deep brain stimulation, and vagus nerve stimulation. Benzodiazepines and sleep medicine is allowed, except on the day of dosing.
- Ongoing tapering off antidepressant or any other serotonergic medication. Prescribed medication must have been stopped at least 5 x elimination half-life. Study personnel will not encourage any tapering off.
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.