Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.
研究概览
简要总结
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, researchers have pursued modifying the treatment parameters to reduce treatment times with some preliminary successes. This study aims to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 22 to 80 years of age.
- •Able to provide informed consent.
- •Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
- •Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy. Participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the SSRI class.
- •Participants may also have a history of intolerance to at least 2 antidepressant medications. These patients with the intolerance history will not be required to be currently taking an antidepressant medication.
- •Participants must qualify as "Moderately Treatment Refractory" or "High Treatment Refractory" using the Maudsley staging method.
- •Meet the threshold on the total HAMD17 score of >/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- •Meet the threshold on the total MADRS score of >/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- •Meet the threshold on the total BDI-II score of >/=20 at both screening and baseline visits (Day -5/-14 and Day 0).
- •In good general health, as ascertained by medical history.
- •If female, a status of non-childbearing potential or use of an acceptable form of birth control. The form of birth control will be documented at screening and baseline.
- •Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable.
排除标准
- •Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- •Female that is pregnant or breastfeeding.
- •Female with a positive pregnancy test at participation.
- •Total HAMD17 score of < 20 at the screen or baseline visits.
- •Total MADRS score of < 20 at the screen or baseline visits.
- •Total BDI-II score of < 20 at the screen or baseline visits.
- •Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
- •Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
- •History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- •Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening.
- •Considered at significant risk for suicide during the course of the study.
- •Cognitive impairment (as noted by previous diagnoses-including dementia).
- •Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- •Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- •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.
- •History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
- •Current (or chronic) use of opiates.
- •History of epilepsy.
- •History of rTMS exposure.
- •History of any implanted device or psychosurgery for depression.
- •Any history of ECT (greater than 8 sessions) without meeting responder criteria
- •History of shrapnel or metal in the head or skull.
- •"Low Treatment Refractory" using the Maudsley staging method.
- •History of cardiovascular disease or cardiac event.
- •History of OCD.
- •History of autism spectrum disorder.
- •History of intractable migraine
- •History of independent sleep disorder.
结局指标
主要结局
Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.
时间窗: Pretreatment (baseline), 1-month post-treatment
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
次要结局
- Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17)(Pre-treatment (baseline) to immediately post-treatment (day 8).)
- Change in the Columbia Suicide Severity Rating Scale (C-SSRS) Score(Pretreatment (baseline) to immediately post-treatment (day 8).)
- Change in the Hamilton Rating Scale for Depression (HAM-6) Score(Baseline (pre-treatment) and at 1-month post-treatment)
- Change From Baseline Functional Connectivity to Immediate Post-treatment(Pretreatment (baseline) to immediately post-treatment (day 8).)
- Change in Baseline Heart Rate Variability to Immediate Post-treatment(Pretreatment to immediate post-treatment (day 8).)
- Change From Baseline Functional Connectivity to 1-month Post-treatment(Pretreatment (baseline) to 1-month post-treatment)
- Change in Baseline Heart Rate Variability to 1-month Post-treatment(Pretreatment to 1-month post-treatment)
研究者
Nolan R
Assistaant Professor, Psychiatry & Behavioral Sciences, Stanford University School of Medicine
Stanford University