NCT02544607已完成4 期
Baseline Insular Dysfunction as a Predictor of Ketamine's Antidepressant Effects in Anxious Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
研究概览
简要总结
Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has been shown to last for up to one month. MRI technology will be used before and after ketamine for patients with depression to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
详细描述
Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS). MRI data will also be analyzed to examine the extent to which certain brain areas predict ketamine's antidepressant effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with Depression
- •Patients will:
- •be 18-64 years old,
- •read, understand, and provide written informed consent in English,
- •meet criteria for a primary psychiatric diagnosis of major depressive disorder for ≥ 4 weeks,
- •have a history of ≥1 failed medication trial during the current depression
- •be on a stable antidepressant and psychotherapy regimen for ≥28 days,
- •maintain a treating doctor who is in agreement with study participation,
- •have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
- •be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
- •be of non-childbearing potential or use of an acceptable form of birth control (females only),
- •be right handed.
排除标准
- •Patients with Depression
- •Patients will be excluded if any of the following criteria are met:
- •delirium or dementia diagnosis, 2) unstable medical illness or clinically significant laboratory results, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects or alter brain morphology (e.g., traumatic brain injury), 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders, 6) active substance use disorders (except nicotine and caffeine) within the past six months or past history of ketamine/PCP abuse, 7) requirement of excluded medications that may interact with ketamine, 8) weigh >250 lbs., 9) pregnancy, breastfeeding, or unacceptable means of birth control (females only) 10) presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)), 11) current serious suicidal or homicidal risk, or 12) concurrent participation in other research studies.
- •--------------------------------------------------------------------------------------
- •Inclusion Criteria: Healthy Controls
- •Healthy Controls will:
- •be 18-64 years old,
- •read, understand, and provide written informed consent in English,
- •have a reliable chaperone accompany them home following the completion of the ketamine infusion day,
- •be generally healthy, as assessed by medical history, physical examination (including vital signs), clinical laboratory evaluations, and electrocardiogram (EKG),
- •be of non-childbearing potential or use of an acceptable form of birth control (females only), and
- •be right handed.
- •Exclusion Criteria: Healthy Controls
- •Healthy controls will be excluded if any of the following criteria are met:
- •current or past psychiatric diagnosis (excluding phobias), including alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine),
- •presence of MRI contraindications (e.g., presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips)),
- •presence of medical illness likely to alter brain morphology and/or physiology (e.g., traumatic brain injury),
- •requirement of excluded medications that may interact with ketamine,
- •presence of psychiatric disorders in first-degree relatives,
- •pregnancy, breastfeeding, or unacceptable means of birth control (females only), or
- •weight >250 lbs.
研究组 & 干预措施
Ketamine + MRI
Experimental
All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).
干预措施: Ketamine (Drug)
Ketamine + MRI
Experimental
All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging (MRI).
干预措施: Magnetic Resonance Imaging (MRI) (Other)
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.
时间窗: 4 hours
Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms Change will be calculated by difference between HDRS from Minute 0 to Minute 240.
次要结局
- Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)(4 hours)
- Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)(4 hours)
- Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)(4 hours)
- Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)(4 hours)
研究者
Cristina Cusin, MD
Cristina Cusin, M.D.
Massachusetts General Hospital
研究点 (1)
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