A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 3
- 主要终点
- HAM-D17 score
研究概览
简要总结
This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.
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
- Double (Participant, 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 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 HAMD-17 item
- •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
HFL rTMS
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
干预措施: HFL rTMS (Device)
iTBS
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
干预措施: iTBS (Device)
结局指标
主要结局
HAM-D17 score
时间窗: baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment
Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. 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
Daniel Blumberger
Medical Head, Temerty Centre for Therapeutic Brain Intervention
Centre for Addiction and Mental Health