Biomarker Discovery for Suicide Precision Circuit Therapeutics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Suicidal Ideation Severity
研究概览
简要总结
This is a prospective observational biomarker study assessing changes in clinical, behavioral, neuroimaging, and neurophysiological measurer following ketamine/esketamine or electroconvulsive therapy (ECT) in adults with suicidal thoughts or behaviors.
详细描述
Suicide remains a major public health challenge, and there is a critical need for objective biomarkers that can improve understanding of suicide risk and guide the development of more effective treatments.
Participants with a mood disorder and moderate to severe suicidal thoughts or behaviors will undergo clinical assessments, behavioral testing, magnetic resonance imaging (MRI), electroencephalography (EEG), and digital monitoring before and after an acute course of ECT or ketamine/esketamine treatment. The study will examine how changes in brain circuits, physiology, behavior, and digital measures relate to improvement in suicidal symptoms. Findings from this study may help identify biomarkers that predict treatment response and support the future development of personalized interventions for suicide prevention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Adults aged 18 to 65 years
- •Diagnosis of a major depressive episode associated with Major Depressive Disorder or Bipolar Disorder
- •Presence of moderate to severe suicidal thoughts or behaviors, as determined by the Beck Scale for Suicide Ideation (BSSI)
- •Scheduled to receive an acute treatment course of electroconvulsive therapy (ECT), intravenous ketamine, or intranasal esketamine as part of routine clinical care
- •Ability and willingness to provide informed consent
排除标准
- •Neurological disorders, particularly conditions associated with known structural brain lesions
- •Inability to meet MRI safety requirements
- •Current alcohol dependence
- •Active symptoms of non-alcohol psychoactive substance withdrawal
结局指标
主要结局
Change in Suicidal Ideation Severity
时间窗: Baseline and post-treatment assessment (approximately 2-8 weeks)
Change in suicidal ideation severity from pre-treatment baseline to completion of the acute treatment course, measured using the Beck Scale for Suicide Ideation (BSSI).
Change in Functional Brain Connectivity
时间窗: Baseline and post-treatment assessment (approximately 2-8 weeks)
Change in functional connectivity within neural circuits implicated in suicidal thoughts and behaviors, measured using resting-state functional magnetic resonance imaging (fMRI). Analyses will focus on circuit-level biomarkers associated with treatment response.
Change in Neurophysiological Circuit Activity
时间窗: Baseline and post-treatment assessment (approximately 2-8 weeks)
Change in neurophysiological measures associated with suicidal thoughts and behaviors, assessed using high-density electroencephalography (EEG).
次要结局
未报告次要终点
研究者
Joan A Camprodon, MD MPH PhD
Chief, Division of Neuropsychiatry and Interventional Psychiatry
Massachusetts General Hospital