NCT05437588招募中不适用
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Clinical phenotype analysis
研究概览
简要总结
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Physically healthy
- •willing and able to provide informed consent (if under 18 also parent or guardian consent)
- •MDD participants:
- •A definite diagnosis of DSM-5
- •a Children's Depression Rating Scale-Revised (CDRS-R) score >=
- •Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score >=4 rated over the last two weeks.
- •Suicide attempt group:
- •1. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.
- •Non-psychiatric controls:
- •1. No history of any major mental illness (excluding specific phobia) or substance use disorder.
排除标准
- •Exclusion criteria:
- •Pregnancy or lactation
- •post-partum state (being within 2 months of delivery or miscarriage);
- •homicide risk as determined by clinical interview
- •any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.
- •recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months
- •use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
研究组 & 干预措施
MDD Participant
Other
Participants with MDD will return at six weeks for a second blood draw and assessments
干预措施: Genetic testing (Genetic)
结局指标
主要结局
Clinical phenotype analysis
时间窗: 6 Weeks
次要结局
未报告次要终点
研究者
Yogesh Dwivedi, PhD
Professor
University of Alabama at Birmingham
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Biomarkers of Antidepressant Response and Suicidal Events in Depressed YouthAdolescentDepressionNCT03547219Seoul National University152
终止
不适用
Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI MedicationsDepressionNCT01681407HaEmek Medical Center, Israel17
已完成
不适用
Exploring a Potential Blood Test to Diagnose Major Depressive DisorderMajor Depressive DisorderNCT00705185Massachusetts General Hospital120
招募中
不适用
Pain, Reward, Attention and Neurocircuitry: Biomarkers of SuicidalitySuicideMajor Depressive DisorderSuicidal IdeationNCT02811198Unity Health Toronto120
撤回
不适用
MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host DiseaseAcute GVH DiseaseNCT02917148Northwell Health