EUCTR2015-003957-16-NL进行中（未招募）1 期
A randomised controlled trial of oral S-ketamine as add-on medication for patients with treatment-resistant major depressive disorder - Oral S-ketamine for treating depression
niversity Medical Centre Groningen0 个研究点开始时间: 2016年8月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •In order to be eligible to participate in this study, a subject must meet all the following criteria:
- •- Male or female, age range: 18 to 80 years;
- •- Signed informed consent;
- •- Good understanding of spoken and written Dutch;
- •- DSM-5 diagnosis of MDD, first or recurrent episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus);
- •- TRD, defined as nonresponse to at least 3 different classes of antidepressants during lifetime, all given in an adequate dose (i.e. defined daily dose) for at least 4 weeks;
- •- At least moderately severe depression, defined by a score higher than 18 on HDRS17;
- •- Current treatment with an officially approved antidepressant medicine.
- •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 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation:
- •- Bipolar depression or depression with psychotic features, according to the DSM-5;
- •- Previous or comorbid schizophrenia spectrum or other psychotic disorder according to the DSM-5, not including MDD with psychotic features;
- •- Comorbid severe personality disorder according to the DSM-5, that is the main reason for treatment;
- •- Previous or comorbid moderate or severe dependence of alcohol or drugs according to the DSM-5, not including tobacco-related and caffeine-related disorders;
- •- Recent (within the last 4 weeks) or current use of cannabis or any other non-prescribed psychoactive compounds, including Saint John’s wort;
- •- Relevant neurological disorder, such as dementia or epilepsy;
- •- Recent (within the last 4 weeks) change of antidepressant treatment;
- •- ECT sessions or any other antidepressant treatment change planned for the period of the study;
- •- Active suicidal intent, defined by scores higher than 2 on HDRS17 for suicidal ideation;
- •- (Suspected) pregnancy, insufficient contraception or lactation. If there is any doubt, a pregnancy test is performed;
- •- Recent (within the last 4 weeks) or current use of benzodiazepine and benzodiazepine-like agents (zolpidem, zopiclone) in excess of 2 mg lorazepam or an equivalent per day;
- •- Recent (within the last 4 weeks) or current use of somatic medication that commonly affects mood, like oral corticosteroids;
- •- Presence of any contra-indication for ketamine use, such as increased intracranial pressure, recent myocardial infarction or other relevant cardiac problems, severe hypertension, severe hyperthyroidism, severe liver problems, severe kidney problems, or the use of medication that ketamine interacts with on a major level, such as monoamine oxidase inhibitors;
- •- Vision or hearing problems that cannot be corrected and that interfere with the ability to comply with treatments and/or assessments;
- •- Mental incompetence to provide informed consent, based on the judgment of the general practitioner or treating psychiatrist of the participant;
- •- Inability to comply with treatments and/or assessments, based on the judgment of the general practitioner or treating psychiatrist of the participant.
研究者
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