Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in MADRS score
研究概览
简要总结
The goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (TMS) can help people with depression and suicidal thoughts. The treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (MRI) to guide which part of the brain to target. This study tests whether this treatment is a helpful and practical option for adolescents and young adults who are depressed and have suicidal thoughts.
We want to see if:
- This treatment is feasible and acceptable to patients
- It can reduce depression and suicidal thoughts
- It can lower the chance of going to the hospital
- It affects daily functioning (school, work, relationships)
All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Able to provide informed consent
- •age 15-25 years
- •Discharged within the past week from the ED for chief complaint of SI OR recently admitted in urgent health care setting or seen in outpatient clinic for depression-related suicidal ideation
- •Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)
排除标准
- •Unable to consent (due to medical condition, psychosis, substance use, etc)
- •Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
- •Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
- •Untreated, active psychosis
- •Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
- •Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
- •Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
研究组 & 干预措施
TMS
干预措施: TMS (Device)
结局指标
主要结局
Change in MADRS score
时间窗: 1 week
Change in depressive symptoms as measured by The Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-rTMS treatment. MADRS scores range from 0 to 60, with higher scores reflecting greater severity of depressive symptoms.
次要结局
- Change in C-SSRS score(1 week)
- Health utilization rate(1 week, 1 month)
- Change in Q_LES_Q_SF score(1 week and 1 month)
研究者
Se Ri (Sally) Bae, MD
Medical Resident
University of California, Davis