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Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer,a randomized double-blind study with the possibility of entering open extension
EU CTIS ID: 2024-517747-31-00
What this study is testing
evaluation of the effectiveness of psilocybin (active substance 1) in depression comorbid to oncological disease treatement in 4 weeks (day 28) from its administration, compared to ketamine (active substance 2) and midazolam (control substance)
- 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
- Men and women aged 18‒75 years
- A diagnosis meeting diagnostic criteria for a depressive syndrome (F41.2, F32.1, F32.2) comorbid with an oncological disease that: and) is at an advanced stage according to the judgment of the referring oncologist/hematoncologist/internist/paliatrician, or b) is with a poor prognosis (median survival of 5 years or less), or c) currently progressing, or d) shows recurrence, or e) is in the phase of controlled disease, since the oncological dg. at least 6 months have passed, but the patient still has reactive depressive comorbidity
- In terms of antidepressant treatment, patients who: a) have not used and do not regularly use any standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD), b) are currently using standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD) for at least 6 weeks in a stable dose, but the treatment did not provide them with a satisfactory psychological state, c) they underwent psychosocial interventions (counseling, psychotherapy, consultation of the support and palliative team), but these interventions did not provide them with a satisfactory state.
- The patient's cognitive ability to fully understand the information about CT and the study questionnaires.
- Each patient must have a secured caregiver (close relative, relative) who will accompany the patient to the 1st visit, pick up the patient upon discharge after (each) session with the substance (or after discharge from hospitalization) and will be in personal contact with the patient for at least 5 days in week. This caregiver must be available throughout the clinical trial.
- Participants of childbearing age/preserved fertility must agree to use prescribed methods of contraception and avoid pregnancy for the duration of participation in the clinical trial: a) Women – we require the correct use of at least a barrier contraceptive method (non-hormonal intrauterine device and/or condom and/or vaginal pessary) or sexual abstinence. Hormonal contraception is not required (combined hormonal contraception - in oral, vaginal or transdermal drug form / progestagen hormonal contraception combined with ovulation inhibition - in oral or injectable drug form / intrauterine device), but is accepted if the patient is already using it and it is not contraindicated due to to oncology dg.) b) Men – use of at least an adequate barrier contraceptive method (condom) or sexual abstinence.
You likely can't join if
- Oncological disease with known invasion of the CNS or other serious CNS disease (the exception is asymptomatic CNS involvement in hematological diseases that have been treated with intrathecal cytostatics or radiotherapy). In case of risk of invasion of the underlying disease into the CNS, the patient can only be included in the study if CNS imaging (CT/MR) was performed with negative findings.
- The patient's condition does not allow compliance with the rules of concomitant treatment (see chapters 6.5 and 6.6 of the protocol)
- Known intolerance or allergy to psilocybin, ketamine, midazolam or other drugs from the benzodiazepine group
- Pregnancy or breastfeeding
- Liver dysfunction with GGT, AST, ALT values > 5x upper limit of normal, total bilirubin > 50 μmol/l
- Cardiovascular instability in the sense of uncorrected hypertension (initial BP values ≥ 140/90 mm Hg – average value of 3 measurements), angina pectoris, heart failure or pre-existing clinically significant changes in the ECG (significant conduction disturbances, significant arrhythmias) or tachycardia (initial values ≥ 100 beats/min – average value from 3 measurements)
See the full eligibility criteria
Who can join
- Men and women aged 18‒75 years
- A diagnosis meeting diagnostic criteria for a depressive syndrome (F41.2, F32.1, F32.2) comorbid with an oncological disease that: and) is at an advanced stage according to the judgment of the referring oncologist/hematoncologist/internist/paliatrician, or b) is with a poor prognosis (median survival of 5 years or less), or c) currently progressing, or d) shows recurrence, or e) is in the phase of controlled disease, since the oncological dg. at least 6 months have passed, but the patient still has reactive depressive comorbidity
- In terms of antidepressant treatment, patients who: a) have not used and do not regularly use any standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD), b) are currently using standard antidepressants (SSRI, SNRI NaSSA, SARI, tricyclic and tetracyclic AD) for at least 6 weeks in a stable dose, but the treatment did not provide them with a satisfactory psychological state, c) they underwent psychosocial interventions (counseling, psychotherapy, consultation of the support and palliative team), but these interventions did not provide them with a satisfactory state.
- The patient's cognitive ability to fully understand the information about CT and the study questionnaires.
- Each patient must have a secured caregiver (close relative, relative) who will accompany the patient to the 1st visit, pick up the patient upon discharge after (each) session with the substance (or after discharge from hospitalization) and will be in personal contact with the patient for at least 5 days in week. This caregiver must be available throughout the clinical trial.
- Participants of childbearing age/preserved fertility must agree to use prescribed methods of contraception and avoid pregnancy for the duration of participation in the clinical trial: a) Women – we require the correct use of at least a barrier contraceptive method (non-hormonal intrauterine device and/or condom and/or vaginal pessary) or sexual abstinence. Hormonal contraception is not required (combined hormonal contraception - in oral, vaginal or transdermal drug form / progestagen hormonal contraception combined with ovulation inhibition - in oral or injectable drug form / intrauterine device), but is accepted if the patient is already using it and it is not contraindicated due to to oncology dg.) b) Men – use of at least an adequate barrier contraceptive method (condom) or sexual abstinence.
What rules you out
- Oncological disease with known invasion of the CNS or other serious CNS disease (the exception is asymptomatic CNS involvement in hematological diseases that have been treated with intrathecal cytostatics or radiotherapy). In case of risk of invasion of the underlying disease into the CNS, the patient can only be included in the study if CNS imaging (CT/MR) was performed with negative findings.
- The patient's condition does not allow compliance with the rules of concomitant treatment (see chapters 6.5 and 6.6 of the protocol)
- Known intolerance or allergy to psilocybin, ketamine, midazolam or other drugs from the benzodiazepine group
- Pregnancy or breastfeeding
- Liver dysfunction with GGT, AST, ALT values > 5x upper limit of normal, total bilirubin > 50 μmol/l
- Cardiovascular instability in the sense of uncorrected hypertension (initial BP values ≥ 140/90 mm Hg – average value of 3 measurements), angina pectoris, heart failure or pre-existing clinically significant changes in the ECG (significant conduction disturbances, significant arrhythmias) or tachycardia (initial values ≥ 100 beats/min – average value from 3 measurements)
- Myasthenia gravis
- Epilepsy incl. history of isolated epileptic seizures
- Renal insufficiency with a GFR value of less than 0.66 ml/s/1.73 m2 according to CKD-EPI (creatinine)
- Known paraneoplastic syndrome or ectopic production of hormones by the primary tumor, within which hypercalcemia, Cushing's syndrome, hypoglycemia, SIADH or carcinoid syndrome could occur
- Diabetes mellitus on insulin or corrected with oral antidiabetic drugs, if there is a history of clinically significant hypoglycemia
- Myocardial infarction less than 6 months ago
- Glaucoma
- Untreated or imperfectly compensated hyperthyroidism
- Any current or anamnestic psychotic illness from the range of diagnoses F2x.x
- Current or anamnestic bipolar affective disorder F31.x and manic phase F30.x
- Current major depressive episode with psychotic symptoms F32.3 and F33.3
- Presence of suicidal ideation/behavior on the C-SSRS Lifetime/Recent (L/R) version (specifically, a “yes” answer to question 5 in the past 1 month and/or any “yes” answer to the suicidal behavior questions in the past 3 months) and /or based on clinical examination
- Organic mental disorders including symptomatic F00.x-F09.x
- Psychotic disorders caused by the use of addictive substances (F10.x – F19.x), dissociative disorder (F44.x), eating disorders (F50.x), emotionally unstable, or borderline disorder (F60.3)
- Current or anamnestic alcohol or drug addiction F1x.x. (except opioids and medicinal cannabis used in accordance with the controlled treatment of the underlying disease), if abstinence for at least 2 years cannot be proven
- Undergoing electroconvulsive therapy less than 3 months ago
- A stroke and/or TIA less than 6 months ago
- First-degree relative of a patient suffering from schizophrenia, other psychotic disorder (unless caused by a substance or medical condition)
- Inappropriateness of patient inclusion based on the clinical judgment of the examining physician
- Clinically significant peripheral vascular diseases (acute venous thrombosis, chronic venous insufficiency in the stage of leg ulcers, ischemic disease of the lower limbs in the stage of claudication)
- Dyspnea of any etiology higher than NYHA II, acute respiratory failure or severe respiratory insufficiency, sleep apnea syndrome
- Severe thrombocytopenia < 30 x 10 9/l, resistant to substitution
- Neurological foci findings
- Impossibility of oral administration of the study medication in the form of capsules
- Estimated patient survival time less than 4 months
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.