NCT02992496Unknown2 期
Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
- •Hamilton depression rating scale score ≥ 19
- •Willingness and competence to sign the informed consent form
- •Stable psychopharmacological treatment for 10 days (except benzodiazepines)
排除标准
- •Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
- •Prior use of ketamine
- •Pregnancy/Breast feeding
- •Instable arterial hypertension >170/110mmHg
- •Hepatic dysfunction
- •Hyperthyreosis
- •History of glaucoma
- •Neurodegenerative disorders
- •Any unstable medical illness
- •History of substance abuse within the past 12 months
- •History of psychosis
- •Failure to comply with the study protocol or to follow the instructions of the investigating team
- •Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
研究组 & 干预措施
Ketamine treatment group
Active Comparator
Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.
干预措施: Ketamine (Drug)
Control group
Active Comparator
Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
干预措施: Midazolam Hydrochloride (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 1 week
次要结局
- Hamilton Depression Rating Scale(1 week)
- Clinician Administered Dissociative States Scale (CADSS)(2 weeks)
研究者
Rupert Lanzenberger
Assoc.-Prof., MD PD
Medical University of Vienna
研究点 (1)
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