Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tolerability and Safety
研究概览
简要总结
Evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD).
详细描述
The overall goal of this study is to evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinical trial enrolling 14- to 18-year-old inpatients with MDD with or without obsessive compulsive disorder (OCD). Participants (n=60) will be randomized to receive either active or sham TMS during hospitalization, with follow-up assessments continuing for 12 months post-discharge. Outcomes will include safety, tolerability, treatment adherence, depressive symptom change, suicidal ideation, and time to psychiatric readmission. This study will provide foundational data to support the clinical integration of TMS into inpatient care for adolescents with treatment-resistant depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
- •Aged 14 years to 18 years, inclusive.
- •Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview.
- •Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score >
- •Participants are not required to discontinue current interventions
排除标准
- •Participation in an investigational drug trial within the past three months.
- •Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. ventriculoperitoneal shunt, pacemaker, medical pump).
- •Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations)
- •Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation)
- •For female subjects of childbearing potential, a positive urine pregnancy test.
研究组 & 干预措施
Active dTMS Treatment
Participants will receive active dTMS 5 sessions per day for 5 days
干预措施: Transcranial Magnetic Stimulation (Device)
Sham controlled
Sham dTMS 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12th month follow-up -reduction in depression symptoms from screening - they will then become eligible for and offered active, open-label treatment.
干预措施: Transcranial Magnetic Stimulation Sham (Device)
结局指标
主要结局
Tolerability and Safety
时间窗: Completed before and immediately after the intervention
We will collect and summarize descriptive data on discomfort and adverse events using Sections IV of the TMS Adverse Events and Associated Sensations Questionnaire (TMSens\_Q). This captures typical sensory experiences or side effects, e.g. scalp tingling or headache) as well as adverse events (e.g. syncope). Tolerability will be characterized based on sensory experiences and side effects, comparing active to sham treatment. Safety will be further assessed by the rate of early discontinuation due to intolerability or adverse events using the CCHMC Adverse Event form. Tolerability: Unit of measure: frequency and severity of sensory experiences and adverse events, e.g. scalp tingling or headache, syncope). Safety: Unit of measure: Rate of early discontinuation or withdrawal of treatment due to intolerability or adverse events.
次要结局
- Depression Symptoms(Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up)
- Suicide Risk(Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up)
- Hospitalization(Completed monthly for the first 6 months, 9th and 12th month follow up)
研究者
Rana Elmaghraby
ASSISTANT PROFESSOR
Children's Hospital Medical Center, Cincinnati