NCT05294835招募中2 期
Impact of Ketamine on Epigenetic Age (IKEA)
TruDiagnostic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Epigenetic Age
研究概览
简要总结
This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.
详细描述
Subjects with MDD or PTSD will have a series of six ketamine infusions over two to three weeks.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18-64 years old of any sex, gender orientation, and ethnicity
- •Read, understand, and provide written informed consent in English,
- •Meet criteria for a primary psychiatric diagnosis of Major Depressive Disorder (MDD) or Post-traumatic Stress Disorder (PTSD) for greater than 4 weeks,
- •Have a history of at least 1 failed medication trial targeting MDD or PTSD
- •Have a reliable form of transportation to lodging or home following the completion of each ketamine infusion treatment day,
- •Be generally healthy, as assessed by medical history, physical examination (including vital signs), and clinical laboratory evaluations,
- •Be of non-childbearing potential or utilizing an acceptable form of birth control (females-only)
- •Report a pre-treatment symptom level of ≧15 on the PHQ-9 or ≧ 33 on the PCL-5
- •Consent to participation in venipuncture, drug test, pregnancy test (for females) psychiatric evaluation, rating scale completion and ketamine infusion treatment series of six over the course of two to three weeks.
排除标准
- •Delirium or dementia diagnosis,
- •Unstable medical illness or clinically significant laboratory results,
- •History of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at high risk for possible cardiac side effects, or uncontrolled hypertension
- •History of multiple adverse drug reactions,
- •Current or past history of psychotic disorder or psychotic symptoms,
- •Current manic symptoms,
- •Active substance use disorders with the exception of nicotine and caffeine, within the past six months or any past history of ketamine or PCP abuse,
- •Requirement of excluded medications that interact with ketamine,
- •Pregnancy, breastfeeding or unacceptable means of birth control in a female of child-bearing age,
- •Current acute suicidal or homicidal risk,
- •Previous exposure to ketamine
研究组 & 干预措施
Ketamine Infusion
Experimental
subanesthetic ketamine infusion (0.5mg/kg) over 2-3 weeks
干预措施: Ketamine (Drug)
结局指标
主要结局
Epigenetic Age
时间窗: Biological age will be compared from baseline to study completion, an average of five weeks
DNA Methylation-derived epigenetic age
次要结局
- Degree of Treatment Response(Assessment will compare the difference in PHQ-9/PCL-5 scores from baseline to after treatment with change in biological age from baseline to post-treartment.)
- Severity of Illness and baseline epigenetic age(Assessment will evaluate the correlation of data collected at baseline with data from after treatment is completed, on average five weeks)
- Severity of Illness and post-treatment epigenetic age(Assessment will evaluate the correlation of data collected at baseline with biological age assessed after treatment is complete, on average five weeks)
研究者
研究点 (1)
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