Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
研究概览
简要总结
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.
A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
详细描述
This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
- •Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- •Currently an inpatient at Stanford Hospital
- •Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
- •Qualifies and has access to outpatient rTMS treatment
排除标准
- •Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
- •Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
- •History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
- •Shrapnel or any ferromagnetic item in the head
- •Pregnancy
- •Autism Spectrum disorder
- •Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- •Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
- •Cognitive impairment (including dementia)
- •Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
- •Current mania
- •Current unmanageable psychosis
- •Showing symptoms of withdrawal from alcohol or benzodiazepines
- •Parkinsonism or other movement d/o determined by PI to interfere with treatment
- •More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
- •Any other indication the PI feels would comprise data.
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS) Score
时间窗: After all stimulation sessions have been completed (approximately 48 hours after the final session)
A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of \<10. Data are presented as a raw score point change.
次要结局
- Change in Beck Depression Inventory II (BDI-II)(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Biomarker Analysis in Patient Blood (Plasma) Samples(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Biomarker Analysis in Patient Stool Samples(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Performance on the NIH Toolbox(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Scale of Suicidal Ideation (SSI) Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Young Mania Rating Scale (YMRS)(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Resting-state Recordings and TMS-evoked Potentials in EEG Data.(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Biomarker Analysis in Patient Saliva Samples(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Heart Rate Variability(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS-20) Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in th Quality of Life Enjoyment and Satisfaction Questionnaire-short Form Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change in Immediate Mood Scaler (Ims-12) Depression Subscale Score(After all stimulation sessions have been completed (approximately 48 hours after the final session))
研究者
Nolan R
Assistant Professor, Director, Interventional Psychiatry Clinical Research, Director, Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Stanford University