NCT05991232撤回1 期
Repeated Neurocognitive Measurements in Depressed Patients
Jay Fournier1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- fMRI resting state connectivity
研究概览
简要总结
In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants will:
- •be between the ages of 18 and 60 years,
- •score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)
- •possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
排除标准
- •All participants:
- •Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);
- •Failure to meet standard MRI inclusion criteria: those who have cardiac pacemakers, neural pacemakers, cochlear implants, metal braces, or other non-MRI-compatible metal objects in their body. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results.
- •Acute suicidality or other psychiatric crises requiring treatment escalation. We will use the Columbia Suicide Severity Rating Scale (CSSRS) as both an initial exclusion criteria (CSSRS "Baseline/Screening" Version for past 1month period) and as grounds for rescue/removal (CSSRS "Since Last Visit" form). The CSSRS will be administered using a paper form by an experienced and thoroughly trained clinical assessor on the study team. Subjects with CSSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- •Changes made to treatment regimen within 4 weeks of baseline assessment.
- •Reading level <6th grade as per patient self-report.
- •Patients who have received ECT in the past 2 months prior to Screening.
- •Ketamine phase subsample additional exclusion criteria:
- •Patients currently taking any psychotropic medication.
- •Lifetime recreational ketamine or PCP use
- •Current pregnancy or breastfeeding
- •For ketamine phase entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.
- •Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.
- •Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.
- •Patients with one or more seizures without a clear and resolved etiology.
- •Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
- •Past intolerance or hypersensitivity to ketamine.
- •Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan, Dcycloserine], or the mu-opioid receptor.
- •Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
研究组 & 干预措施
Intravenous Ketamine
Experimental
Open-label ketamine infusion
干预措施: Intravenous Ketamine (Drug)
结局指标
主要结局
fMRI resting state connectivity
时间窗: 24hrs post-intervention
directed connectivity beta weights between default mode, frontoparietal, limbic/affective, and salience networks (larger beta weight = stronger connectivity)
次要结局
- Montgomery-Asberg Depression Rating Scale(12 days post-intervention)
- Quick Inventory of Depressive Symptoms(12 days post-intervention)
- Hamilton Depression Rating Scale(12 days post-intervention)
- Quick Inventory of Depressive Symptoms(24hrs post-intervention)
- Quick Inventory of Depressive Symptoms(5 days post-intervention)
- Montgomery-Asberg Depression Rating Scale(24hrs post-intervention)
- Montgomery-Asberg Depression Rating Scale(5 days post-intervention)
- Hamilton Depression Rating Scale(24hrs post-intervention)
- Hamilton Depression Rating Scale(5 days post-intervention)
研究者
Jay Fournier
Associate Professor, Department of Psychiatry & Behavioral Health
Ohio State University
研究点 (1)
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