Exploring Ketamine's Effects on Depression and Anxiety in Adults With Low Vision
The purpose of this open-label study is to evaluate the effects of a single intravenous infusion of ketamine on depression and anxiety in adults with low vision.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Study Team
- 电话号码：650-497-5942
- 邮箱：glaucomatrials@stanford.edu
研究联系人备份
- 姓名：Kalena Caravalho
- 电话号码：650-723-4095
- 邮箱：ocdresearch@stanford.edu
学习地点
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California
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Stanford、California、美国、94305
- Department of Psychiatry & Behavioral Sciences
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接触：
- OCD Research
- 电话号码：650-723-4095
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria for Participants with Low Vision:
- Ages 18 and older
- Qualifies as a low vision participant based on ophthalmology assessments
- Capacity to provide informed consent
Inclusion Criteria for Healthy Controls:
- Ages 18 and older
- Qualifies as a normal vision participant based on ophthalmology assessments
- Capacity to provide informed consent
- Likely able to tolerate clinical study procedures
- No current or lifetime psychiatric diagnosis
- No current or past use of psychotropic medication
Exclusion Criteria for Participants with Low Vision and Healthy Controls:
- allergy to ketamine
- Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
- Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Low Vision
Adults with low vision, as determined by ophthalmology assessments |
Single intravenous racemic ketamine hydrochloride, 0.5 mg/kg in 100 ml of normal saline, infused over 40 minutes with continuous monitoring of vital signs.
其他名称：
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其他：Healthy Controls
Healthy adults with normal vision and no psychiatric diagnosis |
Single intravenous racemic ketamine hydrochloride, 0.5 mg/kg in 100 ml of normal saline, infused over 40 minutes with continuous monitoring of vital signs.
其他名称：
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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 |
|---|---|---|
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Change in depression symptom severity as measured by the Hamilton Depression Rating Scale 17 (HDRS-17)
大体时间：Baseline (pre-infusion) to 1 week (post-infusion)
|
Change in depression severity is measured by the Hamilton Depression Rating Scale 17 (HDRS-17). For the HDRS-17 the minimum units are 0 and Maximum units on the total scale are 52. The higher the number on the HDRS-17, the more severe the symptoms, a reduction means improvement in depression symptoms. Response is defined as ≥ 50% reduction in score from baseline. |
Baseline (pre-infusion) to 1 week (post-infusion)
|
|
Change in anxiety symptom severity as measured by the Hamilton Anxiety Rating Scale (HAM-A)
大体时间：Baseline (pre-infusion) to 1 week (post-infusion)
|
Change in anxiety severity is measured by the Hamilton Anxiety Rating Scale (HAM-A). For the HAM-A the minimum units are 0 and Maximum units on the total scale are 56. The higher the number on the HAM-A, the more severe the symptoms, a reduction means improvement in anxiety symptoms. Response is defined as ≥ 50% reduction in score from baseline. |
Baseline (pre-infusion) to 1 week (post-infusion)
|
合作者和调查者
调查人员
- 首席研究员：Carolyn I Rodriguez, MD, PhD、Stanford University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.