NL-OMON46103已完成3 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female, age range: 18 to 80 years;
- •- Signed informed consent;
- •- Good understanding of spoken and written Dutch;
- •- DSM-5 diagnosis of Major Depresive Disorder, first or recurrent episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus);
- •- Treatment Resistant Depression, 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.
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.;For the MRI-scanning, there are additional exclusion criteria:
- •- MRI incompatible implants in the body, such as cochlear implants, insulin pumps or other metal implants;
- •- Any risk of having metal particles in the eye, for example due to manual work without proper eye protections;
- •- Tattoos containing red pigments;
- •- Claustrophobia;
- •- The refusal to be informed of structural brain abnormalities that could be detected during the experiment.
研究者
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