EUCTR2018-004480-31-CZ进行中（未招募）1 期
Psilocybin versus ketamine – fast acting antidepressant strategies in treatment-resistant depression
árodní ústav duševního zdraví0 个研究点目标入组 60 人开始时间: 2019年3月5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 18-65
- •2) Diagnosis of moderate to severe depressive disorder without psychotic symptoms - ICD-10 criteria F32.1-2 or F33.1-2 and at the same time MADRS score > 20
- •3) The duration of the current depressive epizode is at least 3 months and maximum 2 years
- •4) Treatement-resistant depression defined as:
- •a) Failure of at least 2 and at most 4 adequate treatments (6 weeks of full therapeutic dose of antidepressant, adequate non-pharmacological treatemment - eg psychotherapy, neurostimulation treatment, phototherapy, etc.) within the current depressive episode, using at least 2 types of antidepressants with different pharmacological mechanisms of action (augmentation is taken as a second treatment) or
- •b) Intolerance of 2 different treatments and 1 adequate treatment or
- •c) Intolerance of 3 different antidepressant treatments.
- •5) Ability to understand the study protocol and to be able to complete all study visits and examinations as defined per protocol.
- •5) Participants in a clinical trial of childbearing potential must agree to the use of prescribed contraceptive methods for the duration of the study:
- •a) Women - Proper use of a highly reliable method of contraception, ie combined hormonal contraceptives (oral, vaginal or transdermal dosage form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable dosage form), non-hormonal intrauterine device or intrauterine device releasing hormones, ev. the presence of bilateral tubal occlusion, a partner's vasectomy, or adherence to sexual abstinence.
- •b) Men - Adherence to sexual abstinence or the use of an adequate contraceptive method (ie condom) in case of sexual intercourse.
- •Periodic abstinence is not considered an acceptable method. The clinician, together with the volunteer, chooses the most appropriate method of contraception. The chosen method of contraception will be documented in the screening visit.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Serious psychiatric comorbidity (axis I MINI, ICD-10 F0.X - F99.X, the intensity of the disorder will be clinically assessed by the study clinician)
- •2) The current depressive phase is severe with psychotic symptoms (ICD-10: F32.3, F33.3)
- •3) MADRS suicidality score (item 10)> 4
- •4) Suicideal attempt within last 6 months
- •5) Duration of the current depressive episode longer than 2 years
- •6) Current drug or alcohol dependence (ICD-10: F17.x) with the exception of tobacco and with the exception of abstinence lasting more than 2 years
- •7) Claustrophobia, inability to undergo MR examination
- •8) Pregnancy or breast-feeding or plan to become pregnant within the next 3 months
- •9) Intracranial hypertension, pulmonary hypertension, uncorrected arterial hypertension (BP> 150/100 mmHg)
- •10) Condition after stroke, myocardial infarction in the last 6 months
- •11) Heart failure
- •12) Untreated or decompensated hyperthyroidism
- •13) Glaucoma
- •14) Severe respiratory failure or acute respiratory depression
- •15) History of seizures
- •16) Other serious somatic disease or any other circumstance in which a significant increase in blood pressure would pose a serious threat to health (to be assessed by the study clinician)
- •17) Pacemaker
- •18) Metal implants made of MR incompatible materials
- •19) Regular use of medication that could interact with psilocybin (to be assessed by the investigator)
- •20) Current use of monoamine oxidase inhibitors (MAOIs). Patients can be enrolled if the IMAO treatment will be completely discontinued during tapering at least 14 days prior V0
- •21) Previous experience with psilocybin, hallucinogenic mushrooms or ketamine is possible in a maximum of 10% of patients. This experience must not be during the last 12 months or during the current depressive episode.
- •22) Recent use of antidepressants, antipsychotcis or other drugs with a direct antagonistic effect on 5-HT2A receptors (eg trazodone, mirtazapine, mianserin, risperidone, quetiapine, ketanserine) or discontinuation of their use for less than 7 days before dosing with study medication. Patients can be enrolled, but these drugs must be completeley tapered at least 7 days prior V0.
- •23) Electroconvulsive therapy in the previous 3 months
- •24) Daily use of benzodiazepine anxiolytics higher than the equivalent of 10 mg diazepam
- •25) Allergy to any of the components of study drugs
研究者
相似试验
招募中
2 期
Psilocybin Versus Ketamine in Treatment-Resistant DepressionTreatment Resistant DepressionNCT05383313National Institute of Mental Health, Czech Republic60
进行中（未招募）
1 期
Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer.Depressive disorder comorbid with cancerMedDRA version: 20.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2020-005037-32-CZárodní ústav duševního zdraví60
尚未招募
2 期
Ketamine vs ECT in patients with severe depression.CTRI/2022/11/047630KLES ACADEMY OF HIGHER EDUCATION AND RESEARCH
进行中（未招募）
1 期
Assessing psilocybin as a treatment for depressioMajor Depressive DisorderMedDRA version: 20.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2017-000219-18-GBImperial College London50
尚未招募
2 期
Evaluating the management of treatment resistant depression with psychedelic (psilocybin) assisted psychotherapy (EMPACT)Treatment Resistant DepressionMental Health - DepressionACTRN12623001004651The Australian National University140