EUCTR2020-005037-32-CZ进行中（未招募）1 期
Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer, a randomized double-blind study with the possibility of entering open extension. - PSIKET_002CZE
árodní ústav duševního zdraví0 个研究点目标入组 60 人开始时间: 2020年12月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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