Comparing Different Patterns of rTMS in Major Depression
2018年3月13日 更新者:University Health Network, Toronto
A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression
This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.
研究概览
研究类型
介入性
注册 (预期的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M6J 1H4
- 招聘中
- Centre for Addiction and Mental Health
-
接触:
- Shobha Mehta
- 邮箱:shobha.mehta@camh.ca
-
首席研究员:
- Daniel M Blumberger, MD MSc
-
副研究员:
- Zafiris J Daskalakis, MD PhD
-
Toronto、Ontario、加拿大、M5T 2S8
- 招聘中
- UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
-
接触:
- Laura Schulze
- 电话号码:416-603-5667
- 邮箱:laura.schulze@uhn.ca
-
接触:
- Terri Cairo
- 电话号码:416-603-5667
- 邮箱:terri.cairo@uhn.ca
-
首席研究员:
- Jonathan Downar, MD PhD FRCPC
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Participants are eligible for the study if they:
- are outpatients
- are voluntary and competent to consent to treatment
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD), single or recurrent, or Bipolar Disorder with a current Major Depressive Episode
- are between the ages of 18 and 65
- have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
- have a score ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
- are able to adhere to the treatment schedule
- pass the TMS safety-screening questionnaire
- have normal thyroid functioning and no clinically significant abnormalities on complete blood count (CBC), on pre-study blood work.
Participants are ineligible for the study if they:
- 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
- are pregnant
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
- 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 except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- 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
- have a clinically significant laboratory abnormality, in the opinion of the investigator
- currently (or in the last 4 weeks prior to the study) have taken more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:60 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
|
实验性的:30 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
|
实验性的:0 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min).
|
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
17-Item Hamilton Rating Scale for Depression (HAMD-17)
大体时间:Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).
|
Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment.
A 50% improvement in the score is considered a response to rTMS.
A final score of ≤7 is categorized as remission.
|
Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
大体时间:Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment
|
Outcome measured by a change in BDI-II score from baseline to 1-week post-treatment.
A 50% improvement in the score is considered a response to rTMS.
A final score of ≤12 is categorized as remission.
|
Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年4月1日
初级完成 (预期的)
2019年3月1日
研究完成 (预期的)
2019年9月1日
研究注册日期
首次提交
2016年5月12日
首先提交符合 QC 标准的
2016年5月18日
首次发布 (估计)
2016年5月19日
研究记录更新
最后更新发布 (实际的)
2018年3月14日
上次提交的符合 QC 标准的更新
2018年3月13日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.