NCT02800226已完成3 期
Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
研究概览
简要总结
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients
- •voluntary and competent to consent
- •Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
- •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 of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
- •have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
- •Pass the TMS adult safety screening (TASS) questionnaire
- •have normal thyroid functioning based on pre-study blood work
排除标准
- •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 diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, 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
研究组 & 干预措施
10Hz
Experimental
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks
干预措施: 10Hz (Device)
iTBS
Active Comparator
intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks
干预措施: iTBS (Device)
结局指标
主要结局
Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
时间窗: baseline, 1, 4, and 12 weeks post-treatment
A 50% improvement in the score is considered response to rTMS. A final score of \<8 is categorized as remission.
次要结局
未报告次要终点
研究者
Fidel Vila-Rodriguez
Principle Investigator
University of British Columbia
研究点 (1)
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