NCT07147218进行中（未招募）不适用
Accelerated Transcranial Magnetic Stimulation for Major Depressive Disorder
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Neuronetics
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Change in MADRS score from baseline to post-treatment.
研究概览
简要总结
An open-label, multi-center, prospective study to evaluate feasibility and efficacy of accelerated TMS for patients with Major Depressive Disorder (MDD).
详细描述
This protocol will investigate the feasibility, tolerability and clinical efficacy of an accelerated TMS protocol delivering 36 sessions in 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •15 years and older
- •Able to provide informed consent or/and assent
- •Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)
- •Adult participants failed to respond to at least one prior anti-depressant medication; for adolescent participants, TMS therapy is used as an adjunct treatment as stated in the FDA cleared indications, but failure to respond adequately to prior anti-depressant medication is not required
- •Participant prescribed TMS Therapy to treat MDD by his or her physician independent of potential participation in this clinical study
- •On a stable antidepressant treatment regimen (whether medication, therapy, other methods or no treatment at all) for at least the past 4 weeks and agrees to remain on the same treatment regimen throughout study enrollment
- •Willing to comply with all the study procedures, complete required assessments and visits, and be available for the duration of the study
排除标准
- •Participants satisfy any one or more of the contraindications for TMS per current treatment guidelines as determined by the PI
- •Total MADRS score of < 20 or PHQ-score <10 at the screen or baseline visits
- •Current diagnosis of substance use disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence
- •Displaying symptoms of substance withdrawal
- •History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes
- •Any 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
- •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
- •History of non-response to TMS or ECT
- •History of any implanted device or psychosurgery for depression
- •PI opinion: Considered at significant risk for suicide during the course of the study
- •Have any medical or psychological condition, that in the opinion of the referring psychiatrist or investigator, would prevent the participant from completing the study, put the participant at unacceptable risk or could interfere with study assessments or integrity of the data
研究组 & 干预措施
Treatment Arm
Other
Patients will receive 5 consecutive calendar days of treatments with 6-8 treatments per day for a total of 36 treatments
干预措施: TMS (Device)
结局指标
主要结局
Change in MADRS score from baseline to post-treatment.
时间窗: 2 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. Scores range from 0 to 60, with higher scores indicating greater severity
次要结局
- Change in PHQ-9 from baseline to post-treatment.(2 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
暂停
1 期
Accelerated TMS in PsychosisProdromal SchizophreniaSchizophreniaSchizoaffective DisorderNCT05567848Beth Israel Deaconess Medical Center20
进行中（未招募）
不适用
Rapid Acting Transcranial Magnetic StimulationTreatment Resistant DepressionNCT04739969Stanford University100
进行中（未招募）
不适用
acTBS Treatment for Inpatient Subjects With SuicidalitySuicidalityNCT04197765University of California, Los Angeles40
撤回
不适用
Rapid Acting TMS for Suicide Ideation in DepressionDepressive Disorder, MajorSuicideNCT05100004Stanford University100
已完成
不适用
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)Major Depressive DisorderNCT03718013Sveti Ivan Psychiatric Hospital118