NCT07399756尚未招募不适用
Assessment of Mitochondrial Parameters in Blood Before and After S-Ketamine Treatment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- S-ketamine effects on the mitochondrial
研究概览
简要总结
The goal of this observational study is to learn about the role of mitochondria in response to S-ketamine. in individuals with Treatment-Resistant Depression.
the Research Questions are
- Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?
- Can changes in mitochondrial function serve as biomarkers for predicting or monitoring clinical response to S-ketamine treatment?
Samples will be collected at baseline, 3 hours after the first treatment, and 6 weeks post-exposure, and compared between responders and non-responders
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18-65 years of age Diagnosis of Major Depressive Disorder according to the DSM-V Patient has a HAM-D≥23 Treatment resistant -Did not respond to two antidepressants trial Medically stable: No active physical disease: malignancy, cardiac condition, hypertension , stable medications for the past month etc.
排除标准
- •Known sensitivity to ketamine drug or alcohol abuse Patient taking lithium or corticosteroids Pregnant or breast-feeding has another axis I diagnosis attention deficits disorder a history or current serious neurological, metabolic autoimmune bone marrow, oncologic or additional psychiatric disorders
研究组 & 干预措施
Ketamine inhalation group
Treatment-Resistant Depression patient after Ketamine inhalation
干预措施: S (+) Ketamine (Drug)
结局指标
主要结局
S-ketamine effects on the mitochondrial
时间窗: 3 hours and 6 weeks
Does S-ketamine treatment modulate mitochondrial function in peripheral blood cells, as reflected by mitochondrial content and circulating mitochondrial biomarkers such as GDF15?
次要结局
未报告次要终点
研究者
研究点 (1)
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