Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.
详细描述
Standard rTMS treatment often uses the "Beam-F3" targeting approach to locate a brain region known as the left dorsolateral prefrontal cortex (lDLPFC). However, Beam-F3 does not take into account interindividual variation in brain anatomy. Researchers as Columbia University have found a more accurate and personalized approach that uses MRI-based brain surface parcellation to locate the specific subregion of the lDLPFC most ideal for rTMS treatment. Our study is comparing standard rTMS (Beam-F3) to parcel-guided rTMS for patients 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- •Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
- •At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
排除标准
- •Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
- •Anorexia nervosa or bulimia nervosa within the last year
- •Unstable medical condition by history, physical exam or laboratory results
- •Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- •Contraindications to MRI (based on metal screening form)
- •Meets criteria for claustrophobia
- •Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
- •Neurological or neuromuscular disorder
- •Requires medications for a general medical condition that contraindicate the TMS treatment
- •Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
- •History of ketamine treatment within 6 months
- •History of monoamine oxidase inhibitor (MAOI) within the past month
- •Lacks capacity to consent
- •Taking medications that increase the risk of seizures.
- •For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline and at end of Week 1
Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.
次要结局
- Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)(Baseline and at Week 1)
- Side-effect form (SEF)(Daily from Baseline until Week 1)
- Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)(Baseline and at Week 1)
- Side-effect form (SEF)(Daily from Baseline until Week 1)
- Columbia suicide severity rating scale (C-SSRS)(Baseline and Week 1)