Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)
2022年11月4日 更新者:Entheon Biomedical Corp.
Evaluation of the Effect of Ketamine on Neurological Activity as Measured by Quantitative EEG
This observational study will allow data to be collected to demonstrate changes in brain activity following administration of standard of care (SOC) Ketamine.
By comparing genetic markers across participants, data on impact of genetic markers and response to Ketamine will also be analysed.
This data will contribute to the design of future studies utilizing Ketamine for various psychiatric disorders.
This study will focus on treatment-resistant Major Depressive Disorder (MDD).
研究概览
详细说明
This is an Open Label Observational Study with the primary objective to assess brain activity in patients prior to, during and after Ketamine treatment and to assess genetic markers prior to Ketamine treatment.
This is a non-interventional study that will observe the Electroencephalogram (EEG) pattern of participants who, per standard of care, are treated with intramuscular Ketamine.
The administration of the Ketamine during this study is not considered investigational.
The experimental intervention, measurements via EEG, will be offered to patients of the study site presenting for intramuscular (IM) ketamine treatment per the site's established and evidence-based protocol as part of their regular clinical care.
Participants in this study have already been determined to have a medically appropriate indication for IM Ketamine treatment, independent of enrollment in this study.
Given the requirement, per study protocol, to wear an EEG headset and complete study measures, participants will be compensated by having treatment costs paid by the study sponsor.
There will be 36 participants enrolled at one study site.
研究类型
观察性的
注册 (实际的)
1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Texas
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Austin、Texas、美国、78746
- Heading Health
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Male or female participants with treatment-resistant Major Depressive Disorder aged 21-60 interested in receiving intra-muscular injections of ketamine over 10 sessions in the clinic and willing to wear an electroencephalogram (EEG) headset to measure their brain wave patterns.
描述
Inclusion Criteria:
Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
- Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years
- Score of ≥20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression)
- All genders aged 21 to 60 years of age
- Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
- Willing to wear an Electroencephalogram (EEG) headset and an eye mask
- Willing to listen to ambient sound
- Willing to have a genetic cheek swab
Exclusion Criteria:
- Pregnancy
- Traumatic Brain Injury within past 3 months
- Body weight < 50 kg or > 120 kg
- Coronary heart disease
- Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
- Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
- Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
- Bipolar disorder with current manic, hypomanic or mixed state
- Post-traumatic stress disorder
- Obsessive-compulsive disorder
- Primary substance-use disorder
- Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
Currently using any of the following medications:
- Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment
- Lamotrigine for 6 hours prior to treatment
- Amphetamine-based stimulants for 6 hours prior to treatment
- Monoamine Oxidase Inhibitors (MAO-Is) may be taken but blood pressure must be monitored
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Inter and intra patient variability in neurological activity.
大体时间:Up to 74 days
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Observation of the the inter and intra patient variability in neurological activity.
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Up to 74 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Genetic markers on neurological phenotypes
大体时间:Baseline
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Correlation of neurological phenotypes with genetic markers
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Baseline
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CADSS-6 correlation with neurological phenotypes
大体时间:Up to 67 days
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Correlation of neurological phenotypes of Clinician Administered Dissociative Symptom Scale (CADSS-6).
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Up to 67 days
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QIDS SR-16 correlation with neurological phenotypes
大体时间:Up to 67 days
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Correlation of neurological phenotypes of depressed patients with Quick Inventory of Depressive Symptomatology (QIDS SR-16)
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Up to 67 days
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PMQ-SF correlation with neurological phenotypes
大体时间:Up to 67 days
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Correlation of neurological phenotypes Psychedelic Music Questionnaire Short Form (PMQ-SF)
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Up to 67 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Steven Levine, MD、Heading Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年11月9日
初级完成 (实际的)
2022年10月21日
研究完成 (实际的)
2022年10月21日
研究注册日期
首次提交
2021年10月5日
首先提交符合 QC 标准的
2021年10月15日
首次发布 (实际的)
2021年10月27日
研究记录更新
最后更新发布 (实际的)
2022年11月7日
上次提交的符合 QC 标准的更新
2022年11月4日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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