NCT07834762尚未招募不适用
Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Randomized Sham-Controlled Trial and Mechanistic Exploration
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale
研究概览
简要总结
This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.
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)
盲法说明
tDCS operators, study raters, and clinicians remain blinded throughout the trial.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People between the ages of 18 and 70 at the time of screening.
- •Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- •Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- •Medical records confirming a history of at least moderate treatment-resistance as defined on Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
- •MADRS score of ≥20 at screening.
- •Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.
- •Must be on a stable antidepressant therapeutic regimen for at least 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period. Participants who are not currently on antidepressant treatment are eligible, provided that no discontinuation occurred within the 4 weeks preceding study enrollment.
- •For persons of child-bearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- •Agreement to adhere to Lifestyle Considerations (i.e. must continue with any existing treatments) throughout study duration.
- •For persons of childbearing potential: must take a pregnancy test prior to initiating treatment, with results confirmed as negative by study staff
- •Participants will need to have a stable internet connection and a device compatible with UCSD Microsoft Teams or UCSD Zoom to facilitate remote communication and engagement in study activities.
排除标准
- •Pregnancy this includes breastfeeding or trying to becoming pregnant.
- •History of psychotic or bipolar disorder or depression with psychotic features.
- •Significant borderline personality disorder.
- •Significant comorbid obsessive-compulsive or post-traumatic stress disorder.
- •Previously diagnosed Intellectual Disability or Autism Spectrum Disorder.
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
- •Clinically significant suicidality.
- •Any history of tDCS.
- •Any history of ECT.
- •History of TMS (greater than 15 sessions) without a clinically meaningful response.
- •History of ketamine (greater than 4 sessions) without a clinically meaningful response.
- •History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms.
- •Untreated or insufficiently treated endocrine disorder.
- •Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion).
- •Treatment with an investigational drug or other intervention within the study period.
- •Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score.
- •Require a benzodiazepine with a dose > lorazepam 2 mg/day
- •Has started a new psychotherapeutic process in the past 3 months from screening.
- •Use of potentially irritant topical treatments (ex: retinoids, alpha hydroxy acids).
研究组 & 干预措施
Active spaced-tDCS
Active Comparator
Active tDCS applies low-intensity electrical current to the scalp to modulate cortical excitability through subthreshold shifts in neuronal membrane potentials, influencing synaptic plasticity
干预措施: Spaced Transcranial Direct Current Stimulation (tDCS) (Device)
Sham spaced-tDCS
Sham Comparator
Sham tDCS is a placebo control that simulates the physical sensations of tDCS but does not deliver any actual, prolonged electrical current to the brain.
干预措施: Sham Spaced tDCS (Device)
结局指标
主要结局
Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale
时间窗: Baseline to 4-weeks post treatment
To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.
次要结局
- Changes in The Modified Scale for Suicidal Ideation(1-week post treatment to 10-week post treatment)
- Changes in MADRS with active versus sham spaced tDCS during all post treatment visits(1-week post treatment to 10-week post treatment)
- Changes in Hamilton Depression Rating Scale, 17-item version scores(1-week post treatment to 10-week post treatment)
- Changes in Patient Health Questionnaire-9(1-week post treatment to 10-week post treatment)
- Changes in General Anxiety Disorder-7(1-week post treatment to 10-week post treatment)
- Feasibility (Recruitment)(Baseline clinical assessment to 10 weeks post treatment.)
- Feasibility (Retention)(Baseline clinical assessment to 10 weeks post treatment.)
- Feasibility (Adherence)(Baseline clinical assessment to 10 weeks post treatment)
- Safety of at-home spaced tDCS(Baseline clinical assessment to 10 weeks post treatment)
- Tolerability to spaced tDCS(Baseline clinical assessment to 10 weeks post treatment.)
研究者
Jean-Philippe Miron
MD, PhD
University of California, San Diego
研究点 (1)
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