A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Hospitalizations
研究概览
简要总结
The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.
详细描述
The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program.
The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program.
The study will enroll outpatient and inpatient adolescents (aged 12-18 years) with Major Depressive Disorder (MDD) of at least moderate severity defined as a Children's Depression Rating Scale Revised (CDRS-R) Score of 40 or greater and suicidal ideation defined as a score of 3 or greater on item 13 (Suicidal Ideation) of the CDRS-R.
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)
盲法说明
The use of the MagVenture Cool-B70 A/P coils facilitates blinding of the operator and subjects receiving aTBS or sham treatments. The study team members completing clinical rating scales will also not be allowed in the treatment suite during TBS treatment sessions and will be blinded to treatment assignment. A pre-post treatment expectancy and experience form will ask subjects and parents to make a guess regarding treatment arm (active or sham). Blinded study team members will also be asked to guess treatment assignments for each subject.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients or outpatients
- •Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent
- •Female or male
- •12-18 years of age
- •Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117
- •In a current episode of MDD with duration of at least 4 weeks but less than 3 years
- •Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109
- •Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more
- •Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104
- •On a medically acceptable form of birth control if female
- •Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations.
排除标准
- •Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco).
- •Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123
- •Positive urine drug screen at baseline
- •Seizure history
- •Any family history of epilepsy
- •History of any treatment with electroconvulsive therapy or TMS
- •Use of any investigational drug within 4 weeks of baseline
- •Prior brain surgery
- •Risk for increased intracranial pressure such as a brain tumor
- •Head trauma with loss of consciousness
- •Any true positive findings on the TMS safety screening form
- •Pregnancy or suspected pregnancy
- •Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes).
- •Implanted medication pumps and cardiac pacemakers
- •Any unstable medical condition
- •Inability to adhere to the protocol
研究组 & 干预措施
Sequential bilateral accelerated theta burst stimulation
Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).
干预措施: MagVenture TMS Therapy System w/Theta Burst Stimulation (Device)
Sham seqential billateral accelerated theta burst stimulation
Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).
干预措施: Sham MagVenture TMS Therapy System w/Theta Burst Stimulation (Device)
结局指标
主要结局
Hospitalizations
时间窗: up to 12 months
The total number of hospitalizations related to suicide idealization
Suicidal Ideation
时间窗: up to 12 months
Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.
次要结局
- Cortical inhibition(baseline, 10 days)
研究者
Paul E. Croarkin
Principal Investigator
Mayo Clinic