An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
研究概览
简要总结
The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz [Hz]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects.
详细描述
High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic depression. Given the high degree of ongoing dysfunction in depressed adolescents despite optimization of treatment with antidepressant medications, new concerns regarding suicidal thoughts and behaviors in adolescents treated with antidepressant medications, and the more interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been limited. The primary aim of this study is to examine the safety and feasibility of using 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in adolescents.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
- •Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
- •Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
- •At least six weeks of ongoing SSRI therapy at a stable dose.
- •SSRI Medications will include:
- •Citalopram (Celexa, Cipramil, Emocal, Sepram)
- •Escitalopram oxalate (Lexapro, Cipralex, Esertia)
- •Fluoxetine (Prozac, Fontex, Seromex, Seronil, Sarafem, Fluctin (EUR))
- •Fluvoxamine maleate (Luvox, Faverin)
- •Paroxetine (Paxil, Seroxat, Aropax, Deroxat)
- •Sertraline (Zoloft, Lustral, Serlain)
- •Age 13-18 years.
- •Outpatient, inpatient, or partial hospitalization patients.
- •Capable of providing informed assent/consent (in addition to parent/guardian consent).
排除标准
- •Current Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, pervasive developmental disorder, somatoform disorder, dissociative disorder, posttraumatic stress disorder, obsessive-compulsive disorder, eating disorders, antecedents of autism, and all personality disorders.
- •Active substance dependence (except nicotine) in the past 12 months.
- •Subjects with a history of head trauma, unprovoked seizure history, seizure disorder, or family history of treatment resistant epilepsy.
- •Suspected pregnancy or pregnancy as confirmed by a urine pregnancy test at screening.
- •History of failure to respond to ECT.
- •Metal in the head (except in the mouth), implanted medication pump, cardiac pacemaker.
- •Prior brain surgery.
- •Risk for increased intracranial pressure such as brain tumor.
- •Unable to obtain motor threshold in the subject or motor threshold too high, such that 120% MT cannot be obtained (i.e. >84% of device output).
- •Significant change or increase in antidepressant medications within the last six weeks.
- •Change in psychiatrist, psychologist, or therapist within the last four weeks.
- •Suicide attempt within the past three months.
- •Any suicide attempt or suicidal intent during the study will terminate involvement in this study.
- •Subjects currently on stimulant, antipsychotic, atypical antidepressant or tricyclic antidepressant medications.
- •Unstable medical or neurological conditions that may include hematological, infectious (such as Human immunodeficiency virus [HIV] positive patients) metabolic, or cardiovascular conditions that may preclude safe participation in trial.
- •Subjects undergoing anticoagulant, immune suppressive and 1 or chemotherapy, or those who received any of these therapies </=3 months before enrollment in the study
- •Subjects with intra-cardiac lines
研究组 & 干预措施
rTMS Treatment
All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
干预措施: rTMS Treatment (Device)
结局指标
主要结局
Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
时间窗: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)
The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.
次要结局
- Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)(At study visit 30)