NCT04376697Unknown不适用
Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)
研究概览
简要总结
This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are outpatients
- •are voluntary and competent to consent to treatment
- •are between the ages of 18 and 85, inclusive
- •are able to adhere to the treatment schedule
- •pass the TMS safety-screening questionnaire
- •have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening
排除标准
- •previous rTMS treatment
- •have a history of substance dependence or abuse within the last 3 months
- •have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- •have active suicidal intent
- •have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- •have a diagnosis of any psychotic disorder
- •have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
- •if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
- •clinically significant laboratory abnormality, in the opinion of the investigator
- •currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- •non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
- •any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension
结局指标
主要结局
Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)
时间窗: Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment
Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission.
次要结局
- Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)(Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment)
研究者
Jonathan Downar
Clinician scientist
University Health Network, Toronto
研究点 (2)
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