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临床试验/NCT07568054
NCT07568054尚未招募不适用

Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
MRS & suicidality

研究概览

简要总结

This study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response.

Participants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments.

The study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors.

High-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes.

The study's primary goals are to:

  • Identify neural and electrophysiological correlates of suicide risk.
  • Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide.
  • Determine how CAMS therapy affects brain function and neurochemistry.

By integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.

详细描述

This research study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," is designed to advance understanding of the neurobiological and clinical mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults aged 14-24 years. Suicide is one of the leading causes of death in this age group, and current clinical tools are often insufficient for accurately predicting risk or preventing future suicide attempts. A major limitation in the field is the lack of objective biological markers that can identify individuals at highest risk and guide targeted treatment.

The overarching goal of this study is to investigate how brain structure, function, and neurochemistry differ across varying levels of suicide risk, and how these features change following an evidence-based suicide-specific psychotherapy. The study combines advanced neuroimaging techniques with detailed clinical assessments to provide a comprehensive, multimodal understanding of suicidality.

Participants will be divided into three groups (n=60 total, 20 per group):

  • High Risk (HR): Individuals recently hospitalized following a suicide attempt and with a history of multiple attempts.
  • Medium Risk (MedR): Individuals with chronic suicidal ideation lasting at least one year but no history of attempts.
  • Minimal Risk (MinR): Healthy controls with no history of suicidal ideation or behavior and no psychiatric treatment.

All participants will complete baseline assessments including structured psychiatric interviews and validated rating scales measuring depression, hopelessness, suicidal ideation, and overall functioning. Neuroimaging will include magnetoencephalography (MEG) to measure real-time brain activity and MRI-based techniques such as resting-state functional MRI (rsfMRI), magnetic resonance spectroscopy (MRS), and task-based imaging focused on episodic future thinking.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must be 14-24 years old
  • Subjects must be:
  • High Risk Subjects: Psychiatrically admitted due to a suicide attempt or history of 2 previous suicide attempts
  • Medium Risk Subjects: Suicide ideation for the past year with no suicide attempt
  • Minimal Risk Subjects: No previous history of suicidal ideation or behavior, not taking any psychiatric history or medication, and no family history of suicide
  • Subjects must have the ability to understand and the willingness to sign a written informed consent/assent document
  • Subjects must be English speaking

排除标准

  • Subjects with known history of Autism Spectrum Disorder; non-verbal patients
  • Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education classes full time)
  • Subjects with Schizophrenia or history of any type of psychosis including mood related psychosis and brief reactive psychosis
  • Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for the management of ADHD will not be excluded)
  • Subjects with a history of moderate or severe substance or alcohol use per DSM-5 criteria in the past 6 months
  • Subjects who are currently pregnant or breastfeeding
  • Subjects in custody of Children's Services
  • Subjects with recent bone, tendon, spine or joint surgery
  • Subjects with recent metallic dental implants
  • Subjects weighing less than 30 kg or more than 200 kg

研究组 & 干预措施

High risk (HR)

Active Comparator

patients discharged within 1 week from the hospital for a SA and with a history of 2 previous SAs

干预措施: CAMS (Behavioral)

Minimal risk (MinR)

No Intervention

age-matched controls with no prior history of SI or behavior, not taking any psychotropic medication and no family history of suicide

Medium risk (MedR)

No Intervention

patients with 1 year history of SI with no attempts

结局指标

主要结局

MRS & suicidality

时间窗: 5 years

To investigate the effect of changes in Suicide Status Form (SSF) scores (low severity 1-5 high severity) as a result of CAMS therapy on Glx levels.

次要结局

  • MRS & suicidality(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatiana Falcone, MD

Vice Chair of Research Behavioral Health and Neurological Science, Child and Adolescent Psychiatrist, Assistant Professor of Medicine, Principal Investigator

The Cleveland Clinic

研究点 (1)

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