Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer.

Phase 1

• Conditions: Depressive disorder comorbid with cancer; MedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-005037-32-CZ
• Lead Sponsor: árodní ústav duševního zdraví

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-09
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Men and women aged 18-75
2) Diagnosis meeting the surgical diagnosis of the criteria for depressive syndrome (F41.2, F32.1, F32.2) comorbid with cancer, which:
a) is at an advanced stage at the discretion of the referring oncologist / haematooncologist / internist / palliative doctor, or
(b) has a poor prognosis (median survival of 5 years or less), or
(c) is currently progressing; or
(d) shows recurrence; or
e) is in the phase of controlled disease, from the determination of oncological dg. at least 6 months have elapsed, but the patient still shows reactive depressive comorbidity.
3) From the point of view of antidepressant treatment, patients may be included who:
a) have not used and do not regularly use any standard antidepressants (SSRIs, SNS, NaSSA, SARI, tricyclic and tetracyclic AD),
b) they are currently taking standard antidepressants (SSRIs, SNRI NaSSA, SARI, tricyclic and tetracyclic AD) for at least 6 weeks in a stable dose, but the treatment has not provided them with a satisfactory mental state,
c) underwent psychosocial interventions (counseling, psychotherapy, consultation of the support and palliative team ), but these interventions did not provide them with a satisfactory condition.
4) Cognitive fitness of the patient enabling a full understanding of information about CT and study questionnaires.
5) Each patient must have a secured caregiver (close, relative) who accompanies the patient on the 1st visit, picks up the patient on discharge after (each) Session with the substance (possibly after discharge from hospitalization) and will be in personal contact with the patient for at least 5 days a week. This caregiver must be available throughout the clinical trial.
6) Participants of childbearing potential / maintained fertility must agree to the use of prescribed contraceptive methods and prevent pregnancy during participation in a clinical trial:
a) Women - we require the correct use of at least the barrier method of contraception (non-hormonal intrauterine device and / or condom and / or vaginal pessary) or sexual abstinence. No hormonal contraceptive is required (combined hormonal contraception - in oral, vaginal or transdermal dosage form / gestagen hormonal contraceptive associated with ovulation inhibition - in oral or injectable dosage form / intrauterine device), but is accepted if the patient is already taking it and is not contraindicated due to to oncological dg.)
b) Men - use of an adequate at least barrier contraceptive method (condom) or sexual abstinence.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Oncological disease with known invasion of the CNS or other serious CNS disease (except for asymptomatic CNS involvement in hematological diseases that have been treated with intrathecal cytostatics or radiotherapy)
2) Focal neurological findings
3) Impossibility of oral administration of study medication in the form of capsules
4) Expected survival time <4 months
5) The patient's condition does not allow compliance with the rules of concomitant treatment
6) Known intolerance or allergy to psilocybin, ketamine, midazolam or any other benzodiazepine
7) Pregnancy or breast-feeding
8) Hepatic dysfunction with GGT, AST, ALT values> 5x upper limit of normal, total bilirubin> 50 µmol / l
9) Cardiovascular instability in terms of uncorrected hypertension (baseline BP = 140/90 mm Hg - mean value from 3 measurements), angina pectoris, heart failure or pre-existing clinically significant ECG changes (significant conversion disorders, significant arrhythmia) or tachycardia (baseline values ??= 100 beats - min - average value from 3 measurements)
10) Myocardial infarction less than 6 months ago
11) A stroke and / or TIA less than 6 months ago
12) Clinically significant peripheral vascular diseases (acute venous thrombosis, chronic venous insufficiency in the stage of shin ulcers, ischemic disease of the lower limbs in the stage of claudication)
13) Dyspnoea of ??any etiology higher than NYHA II, acute respiratory failure or severe respiratory insufficiency
14) Severe thrombocytopenia <30 x 109 / l, resistant to substitution
15) Myasthenia gravis
16) Epilepsy incl. history of isolated epileptic seizures
17) Renal insufficiency with GFR less than 0.66 ml / s / 1.73 m2 according to CKD-EPI (creatinine)
18) Known paraneoplastic syndrome or ectopic production of hormones by the primary tumor, which could lead to hypercalcemia, Cushing's syndrome, hypoglycemia, SIADH or carcinoid syndrome
19) Diabetes mellitus treated with insuline or corrected by oral hypoglycaemic agents if there is a history of clinically significant hypoglycaemia
20) Glaucoma
21) Untreated or imperfectly compensated hyperthyroidism
22) Any psychotic illness current or anamnestic from the range of diagnoses F2x.x
23) Current or anamnestic bipolar affective disorder F31.x and manic phase F30.x
24) Current severe depressive episode with psychotic symptoms F32.3 and F33.3
25) Presence of suicidal ideation / behavior based on clinical examination and / or Columbia-Suicide Severity Rating Scale (C-SSRS) of suicidal ideation / behavior based on C-SSRS version of Lifetime / Recent (L / R) (specifically answer yes to question 5 in the last 1 month and / or any yes” answer to suicidal behavior questions in the last 3 months)
26) Organic mental disorders including symptomatic F00.x-F09.x
27) Psychotic disorders caused by the use of addictive substances (F10.x - F19.x), dissociative disorder (F44.x), eating disorders (F50.x), emotionally unstable, resp. border fault (F60.3)
28) Current or anamnestic alcohol or drug addiction F1x.x. (excluding opioids and medical cannabis used in accordance with controlled treatment of the underlying disease), unless abstinence can be demonstrated for at least 2 years
29) Undergoing electroconvulsive therapy less than 3 months ago
30) A relative of a first-order patient suffering from schizophrenia, another psychotic disorder (unless caused by a substance or medical condition)
31) Inadequacy of patient classification based on the clinical judgment of t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified