Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
研究概览
简要总结
This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.
详细描述
Investigators recently developed a form of neuromodulation termed Stanford Neuromodulation Therapy (SNT). SNT-induced remission is associated with significant reductions in the functional connectivity of the neural network underlying explicit suicidal cognition (between sgACC-DMN). This project aims to further elucidate the SNT induced neural network changes underlying explicit suicidal cognition.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22-65 year old at the time of screening on voluntary or involuntary hold
- •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.
- •Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPD II), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- •Endorse suicidal ideation (score ≥9 on the SSI-M).
- •Meet the threshold on the MADRS and HAMD-17 with a total score of >/=20 at baseline.
- •Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI)
- •Have to be TMS naive
- •In good general health, as ascertained by medical history.
- •Scheduled with a psychiatrist
- •Access to clinical rTMS after hospital discharge
- •If participant is of childbearing potential and not already pregnant, must agree to use adequate contraception prior to study and for the duration of study participation.
- •No recent use (for the actual depressive episode) of rapid acting antidepressive agent (ketamine)
排除标准
- •Any abnormalities indicated on previous MRI scans e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke affecting 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: The effects of rTMS on the developing human fetus are incipient and still uncertain (25). Pregnant women will not be enrolled into this study. Women of childbearing potential must agree to use adequate contraception (hormonal / barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Females of childbearing-age, will have a pregnancy test prior to receiving each rTMS stimulation session. Should a woman become pregnant or suspects she is pregnant while participating in this study, she should inform study staff.
- •Autism Spectrum disorder
- •A diagnosis of obsessive-compulsive disorder (OCD)
- •The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
- •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.
- •Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- •Cognitive impairment (including dementia)
- •Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- •Current mania or psychosis
- •Bipolar Affective Disorder I and primary psychotic disorders.
- •Showing symptoms of withdrawal from alcohol or benzodiazepines
- •Parkinsonism or other movement d/o determined by PI to interfere with treatment
- •Desirous of getting ECT and previous intolerant exposure to ECT
- •Any other indication the PI feels would comprise data
- •No access to clinical rTMS after discharge.
- •Previous TMS exposure.
- •Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO).
结局指标
主要结局
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
时间窗: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
The modified Scale for Suicide (m-SSI) is an 18-item clinician rated scale that measures suicidal ideation. Each item is scored from 0-3. Scores are summed for 1 total score. Higher scores indicate more severe suicidal ideation. Investigators will assess change in m-SSI scores at the post-inpatient treatment completion (day 2-7).
次要结局
- Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.(At baseline (day 0) and at post-inpatient treatment completion (day 2-7))
- Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.(At baseline (day 0) and at post-inpatient treatment completion (day 2-7))
研究者
David Spiegel
Professor, Psychiatry and Behavioral Sciences, Stanford School of Medicine
Stanford University