NCT06213324招募中4 期
Neural Circuit-Specific Mechanisms of Ketamine's Effect on Anhedonia and Anxiety in Depression Using Ultra-High Field 7-Tesla MRI
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- sgACC response to the Incentive Flanker Task
研究概览
简要总结
This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on agACC activation and depression symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-65 years;
- •Ability for participant to comply with the requirements of the study as determined by the PI;
- •Capacity to provide informed consent;
- •Meets diagnostic criteria for current MDD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
- •In a current major depressive episode (MDE) of at least moderate severity according to DSM-5;
- •Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year).
- •Women of childbearing potential must have a negative pregnancy test at screening and prior to the infusion.
- •Male or female aged 18-65 years;
- •Capacity to provide informed consent;
- •Women must be using a medically accepted reliable means of contraception (if using an oral contraceptive medication, they must also be using a barrier contraceptive) or not be of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year).
- •Ability for participant to comply with the requirements of the study as determined by the PI;
排除标准
- •Current or history of schizophrenia or other psychotic disorder/episode, bipolar disorder, neurodevelopmental disorder, or neurocognitive disorder;
- •Current major depressive disorder with psychotic features;
- •Substance use disorder within the past 2 years*;
- •Lifetime history of ketamine use disorder;
- •Antidepressant medication within 2 weeks of Baseline (4 weeks for fluoxetine);
- •Severe current illness as reflected by a CGI score >5;
- •Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
- •Clinically significant abnormalities of laboratories, physical examination, or ECG;
- •Positive urine toxicology screen for drugs of abuse at the time of screening, except cannabis;
- •Women who plan to become pregnant, are pregnant or are breast-feeding (because the medical risk of using ketamine during pregnancy and breast-feeding is unknown);
- •Active suicidal intent or plan; CSSRS score >2;
- •Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more;
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- •Current or history of any psychiatric, neurodevelopmental disorder, or neurocognitive disorder;
- •Substance use disorder within the past 2 years*;
- •Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
- •Clinically significant abnormalities of laboratories or physical examination;
- •Positive urine toxicology screen for drugs of abuse at the time of screening, except cannabis;
- •Current pregnancy;
- •Women who are breast feeding;
- •Active suicidal intent or plan; CSSRS score >2;
- •Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, and inability to lie still for 1 hour or more.
研究组 & 干预措施
Ketamine
Experimental
Participants in the ketamine arm will receive a single infusion of ketamine
干预措施: Ketamine (Drug)
Placebo
Placebo Comparator
Participants in the placebo arm will receive a single placebo infusion of normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
sgACC response to the Incentive Flanker Task
时间窗: Baseline
Subgenual anterior cingulate cortex (sgACC) response to reward measured by the BOLD (Blood Oxygen Level Dependent) signal within the sgACC region of the brain, during an fMRI Incentive Flanker Task in healthy controls and in adults with MDD. BOLD signal is the unit of measure of this outcome.
次要结局
- Treatment-related change in sgACC response to the Incentive Flanker Task(Baseline and Day 1)
研究者
James Murrough
Professor of Psychiatry and Neuroscience
Icahn School of Medicine at Mount Sinai
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Low Dose Intravenous Ketamine in Treatment Resistant Depression PatientsTreatment Resistant DepressionNCT02935595The University of Texas Health Science Center, Houston9
已完成
不适用
Synaptic Imaging and Network Activity in Treatment Resistant DepressionDepressive DisorderDepressive Disorder, MajorDepressive Disorder, Treatment-ResistantBipolar Disorder IBipolar Disorder IIMood DisordersAnhedoniaBipolar DisorderNCT05870501King's College London56
已完成
2 期
Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of PainAcute PainChronic Pain, WidespreadSchizophreniaNCT03915938Hospital de Clinicas de Porto Alegre24
撤回
1 期
Intravenous Ketamine Effects on Functional NeuroanatomyDepressionNCT04205890Neurological Associates of West Los Angeles
已完成
2 期
EEG Studies of Ketamine General AnesthesiaAnesthesiaNCT03553758Massachusetts General Hospital16