EUCTR2018-001539-39-CZ进行中（未招募）1 期
Clinical and neurobiological predictors of response to ketamine: towards personalized treatment of depression
árodní ústav duševního zdraví0 个研究点目标入组 40 人开始时间: 2018年5月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Men and women aged 18 to 65 years old
- •Moderate to severe depression without psychotic symptoms, current depressive episode at least 4 weeks and no more than 2 years of duration
- •MADRS score more than 20, CGI 4 or more
- •At least one previous, unsuccessful, adequate treatment for major depression in current episode
- •Stable dose of antidepressants for at least 1 month and clinically appropriate to continue during trial
- •Mental competence to understand and sign the informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Increased vulnerability to psychosis based on a) M.I.N.I. (including past episodes), b) family history of psychosis up to second degree relatives
- •The presence of comorbid psychiatric disorder on Axis I within the criteria of ICD 10 F 0.X – F 99.X, except F 32.1-2, F 33.1/2 less than 6 months prior to enrollment in the study, including drug or alcohol addiction or abstinence for less than 2 years
- •Substantial suicidal risk as judged by the treating psychiatrist
- •Personality disorder that makes participation in the trial difficult
- •Somatic contraindications for the administration of ketamine: severe arterial hypertension (WHO stage 2 and above), congestive heart failure or other severe cardiovascular disease, history of stroke, intracranial hypertension, glaucoma, history of preeclampsia or eclampsia, untreated or decompensated thyroid gland disease, history of seizures
- •History of autoimmune or rheumatologic disease, undergoing biological therapy, chronic infectious disease or severe acute infection within 2 months prior to the trial
- •Concomitant treatment augmentation with lamotrigine, lithium, clozapine or MAOi (monoamine oxidase inhibitor) within the previous 2 weeks before the first visit
- •Medications and/or diseases, that can significantly affect EEG (typical antipsychotics, cranial trauma, encephalitis, epilepsy, etc.), history of electroconvulsive treatment in the 2 month prior to infusion and left-handedness
- •Pregnancy, breastfeeding or the absence of adequate contraception
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