Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS) Score
研究概览
简要总结
The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.
详细描述
The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
- •Acceptance of participation via the informed consent
排除标准
- •Psychiatric comorbidity (except anxiety related disorders)
- •Substance abuse or dependence in the previous 3 months
- •Evidence of structural abnormalities in brain imaging
- •Pregnancy
- •Previous hypersensitivity to ketamine
- •Heart failure or insufficiency
- •Familial or personal history of psychosis
- •Major neurological disease
- •Uncontrolled systemic arterial hypertension
- •MRI contraindications
- •Non-acceptance of participation via informed consent
研究组 & 干预措施
TRD patients
Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.
干预措施: Ketamine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS) Score
时间窗: Change from baseline HDRS Score at 24 hours
次要结局
- Glutamate concentrations in the pregenual cingulate cortex (pgACC)(Change from baseline Glutamate concentrations in the pgACC at 24 hours)
- Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations(Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours)
研究者
Rodrigo Pérez Esparza
Fourth-year Psychiatry Resident
National Institute of Neurology and Neurosurgery, Mexico