Repeated Neurocognitive Measurements in Depressed Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- fMRI Intrinsic Connectivity: Limbic Network
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, lamotrigine, 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
Open-label ketamine infusion
干预措施: Intravenous Ketamine (Drug)
结局指标
主要结局
fMRI Intrinsic Connectivity: Limbic Network
时间窗: 24hrs post-intervention
functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Frontoparietal Control Network
时间窗: 24hrs post-intervention
functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Salience Network
时间窗: 24hrs post-intervention
functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
fMRI Intrinsic Connectivity: Default Mode Network
时间窗: 24hrs post-intervention
functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)
次要结局
- Quick Inventory of Depressive Symptoms(12 days post-intervention)
- fMRI Intrinsic Connectivity: Dorsal Attention Network(24hrs post-intervention)
- fMRI Intrinsic Connectivity: Somatosensory Motor Network(24hrs post-intervention)
- fMRI Intrinsic Connectivity: Visual Network(24hrs post-intervention)
- Montgomery-Asberg Depression Rating Scale(12 days post-intervention)
- Hamilton Depression Rating Scale (Modified Score)(12 days post-intervention)
研究者
Rebecca Price
Associate Professor of Psychiatry and Psychology
University of Pittsburgh