Personalized Therapeutic Neuromodulation for Anhedonic Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation
研究概览
简要总结
This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy termed accelerated intermittent theta burst stimulation (aiTBS) in participants with treatment resistant depression (TRD).
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, the investigators have pursued modifying the treatment parameters to reduce treatment times with an accelerated treatment paradigm. This study aims to further study the accelerated protocol and examine changes 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
- 18 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, between the ages of 18 and 80 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 fMRI assessments and aiTBS 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).
- •The patient has demonstrated a failure of one or more trials of a pharmacological medication as treatment for MDD.
- •MADRS score of ≥20 at screening (Visit 1).
- •Access to ongoing psychiatric care before and after completion of the study.
- •Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period.
- •In good general health, as evidenced by medical history.
- •For females of reproductive 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 throughout study duration.
排除标准
- •History of or current psychotic disorder or bipolar disorder
- •Severe borderline personality disorder
- •Diagnosis of Intellectual Disability or Autism Spectrum Disorder
- •Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
- •Urine screening test positive for illicit substances
- •Acute suicide risk based on clinical judgement or a suicide attempt within the past 6 months
- •Any history of ECT (greater than 8 sessions) without meeting responder criteria
- •Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
- •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
- •Untreated or insufficiently treated endocrine disorder.
- •Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
- •Contraindication to MRI (ferromagnetic metal in their body)
- •Treatment with an investigational drug or other intervention within the study period
- •Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)
- •Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score.
- •Any other condition deemed by the PD to interfere with the study or increase risk to the participant
研究组 & 干预措施
Active TBS-DLPFC
The active group will receive theta-burst TMS stimulation.
干预措施: Active TBS-DLPFC (Device)
Sham Comparator: Sham TBS-DLPFC or DMPFC
The sham group will receive sham theta-burst TMS stimulation.
干预措施: Sham TBS-DLPFC or DMPFC (Device)
Active TBS-DMPFC
The active group will receive theta-burst TMS stimulation.
干预措施: Active TBS-DMPFC (Device)
结局指标
主要结局
Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation
时间窗: Baseline, 1-week post-treatment-initiation
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.
Percentage Change in MADRS Score
时间窗: Baseline, immediate post treatment (up to 2 weeks post baseline), 4 weeks and 8 weeks post treatment.
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item self-survey administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Score range: 0 to 54, higher scores correspond to more severe depressive symptoms.
Percentage Change in SHAPS Score
时间窗: Baseline, immediate post treatment (up to 2 weeks post baseline), 4 week and 8 week post treatment.
The Snaith-Hamilton Pleasure Scale is a 14-item self-report questionnaire designed to measure the reduced ability to experience pleasure. Score range: 0 to 14, higher scores indicate higher levels of anhedonia.
次要结局
未报告次要终点
研究者
David Spiegel
Professor, Department of Psychiatry and Behavioral Sciences, Stanford University
Stanford University