BridgeMD
Effect of psilocybin on the positive valence system in treatment-resistant depression: a pilot clinical neuroimaging study
EU CTIS ID: 2022-501092-11-00
What this study is testing
Comparing the activity of neural circuits responsible for effort assessment before and after psilocybin administration
- 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
- Patient with a DSM-IV diagnosis of a current moderate or severe depressive episode without psychotic features (based on clinical assessment and confirmed by MINI interview and QIDS).
- Patient affiliated to or benefiting from a health insurance
- Patient who has failed to respond to at least 2 sequences of treatment with antidepressants of different classes at the minimum effective dose lasting at least 6 weeks.
- Patient with a score > 10 on the QIDS scale.
- Patient aged ≥ 25 years and < 60 years.
- Patient available for 6-month follow-up.
You likely can't join if
- Patient at moderate or severe risk of suicide according to clinical judgment (based on the MINI suicidality module).
- Patients with contraindications to magnetic resonance imaging
- Patients with allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
- Patients who have used hallucinogenic substances (excluding cannabis) more than 5 times in their lifetime or at any time in the last two months.
- Patients on medication or illicit substances likely to interfere with the effects of psychedelics (urinalysis and breathalyser on D0).
- Patient with regular consumption of alcoholic beverages (>20 drinks/week)
See the full eligibility criteria
Who can join
- Patient with a DSM-IV diagnosis of a current moderate or severe depressive episode without psychotic features (based on clinical assessment and confirmed by MINI interview and QIDS).
- Patient affiliated to or benefiting from a health insurance
- Patient who has failed to respond to at least 2 sequences of treatment with antidepressants of different classes at the minimum effective dose lasting at least 6 weeks.
- Patient with a score > 10 on the QIDS scale.
- Patient aged ≥ 25 years and < 60 years.
- Patient available for 6-month follow-up.
- Good physical health and absence of unstable medical pathology. These pathologies include cardiovascular comorbidities: history of stroke, myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension (greater than 165/95 mmHg at screening); organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroidism and adrenal insufficiency, type I diabetes or insulin-requiring type II diabetes, history of severe hypoglycemia requiring hospital treatment); significant impairment of liver function; glaucoma; symptomatic prostate hypertrophy or bladder neck obstruction.
- Patient able to speak and understand French easily.
- Patient has given free and informed consent.
- Patient has signed consent form.
What rules you out
- Patient at moderate or severe risk of suicide according to clinical judgment (based on the MINI suicidality module).
- Patients with contraindications to magnetic resonance imaging
- Patients with allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
- Patients who have used hallucinogenic substances (excluding cannabis) more than 5 times in their lifetime or at any time in the last two months.
- Patients on medication or illicit substances likely to interfere with the effects of psychedelics (urinalysis and breathalyser on D0).
- Patient with regular consumption of alcoholic beverages (>20 drinks/week)
- Any other major clinically significant concomitant disease which, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk to the participant, should he/she participate in the study.
- Patients with a prolonged QTc interval (>450 ms for men and >470 ms for women).
- Participant planning to donate sperm within three months of psilocybin administration.
- Participants having sexual relations that could lead to pregnancy and who do not agree to use a highly effective contraceptive method (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD) throughout their participation in the study and for at least three months after psilocybin administration.
- Positive serum pregnancy test at inclusion for participants of childbearing age. NB: serum pregnancy test will be performed on the day of psilocybin administration.
- Patients at high risk of adverse emotional or behavioral reactions according to the investigator's clinical assessment (e.g. severe personality disorder, antisocial behavior, severe current stressors, lack of significant social support or any psychotic symptoms identified during interviews).
- Pregnant (confirmed by pregnancy test), parturient or breast-feeding patient, or patient wishing to become pregnant during the study period.
- Patient already participating in an interventional drug study
- Patient in exclusion period determined by another study.
- Patients under court protection, guardianship or curatorship, or under a non-consensual care measure.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
- Patient with positive pregnancy test prior to psilocybin administration
- Any patient who was hospitalized as an outpatient or inpatient between the date of inclusion and the administration of psilocybin.
- Any patient with a confirmed, interrupted or aborted suicide attempt between the date of inclusion and psilocybin administration.
- Any patient who expressed suicidal ideation associated with the planning of a suicidal act (active suicidal ideation) between the date of inclusion and the administration of psilocybin.
- Active substance dependence according to the MINI questionnaire (excluding tobacco).
- Patients whose psychotropic treatment (anxiolytics, antipsychotics, hypnotics, mood regulators) has been modified in the last month.
- Patients with intellectual disabilities (IQ less than or equal to 75).
- Patients with a lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or psychosis not otherwise specified.
- Patients with a family history of schizophrenia, schizoaffective disorder or type 1 bipolar disorder in first- or second-degree relatives.
- Subjects participating in psychotherapy during the study.
- Patients with any unstable disease or physical condition as determined by clinical examination, history or laboratory tests (ECG, blood work at inclusion) Unstable physical conditions include: presence of fever or inflammatory syndrome, unstabilized hypertension or > 180/100, class IV heart failure, respiratory, hepatic or renal failure, and history of stroke, intracranial hypertension or epilepsy under treatment.
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. 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.