Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage change in Hamilton Depression Rating Scale 21-Item score
研究概览
简要总结
This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. In particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 75 years of age.
- •Able to provide informed consent.
- •Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
- •prior exposure to rTMS
- •Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
- •Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
- •Participants are required to have a stable psychiatrist for the duration of study enrollment.
排除标准
- •History of MI, CABG, CHF, or other cardiac history
- •Any neurological conditions
- •History of epilepsy
- •Independent sleep disorder
- •Autism Spectrum Disorder
研究组 & 干预措施
Accelerated theta burst treatment
All participants will receive theta-burst TMS.
干预措施: Intermittent theta-burst stimulation (iTBS) delivered to the L-DLPFC (Device)
Accelerated theta burst treatment
All participants will receive theta-burst TMS.
干预措施: Intermittent theta-burst stimulation (iTBS) delivered to the bilateral DLPFC (Device)
结局指标
主要结局
Percentage change in Hamilton Depression Rating Scale 21-Item score
时间窗: Difference between baseline and one month after aiTBS treatment
A 21 item clinical assessment tool used to rate a patient's level of depression - total scores range from 0-63 with higher scores indicating worse depression
Change in Hamilton Depression Rating Scale 21-Item Score
时间窗: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)
A 21 item clinical assessment tool used to rate a patient's level of depression. The total scores range from 0 to 63 with higher scores indicating worse depression.
次要结局
- Change in Hamilton Rating Scale for Depression (HAMD-6)(Every day of stimulation, follow-up every 2 weeks after treatment for 6 months by telephone])
- Change from baseline functional connectivity(Pretreatment, immediately post-treatment, 4 weeks post-treatment)
- Change in Hamilton Rating Scale for Depression (HAMD-17)(Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment)
- Change in The Scale for Suicide Ideation(Pretreatment, immediately posttreatment, 2 weeks posttreatment, 4 weeks posttreatment)
- Change in Beck Depression Inventory (BDI)(Pretreatment, immediately post-treatment, 4 weeks post-treatment)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS)(Pretreatment, immediately post-treatment, 4 weeks post-treatment)
- Change in Hamilton Rating Scale for Depression (HAMD-17)(Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment)
- Change in The Scale for Suicide Ideation(Baseline, immediately post treatment, 2 weeks post treatment, 4 weeks post treatment)
- Change in Hamilton Rating Scale for Depression (HAMD-6)(Every day of stimulation on days (visits) 1, 2, 3, 4, and 5)
- Change From Baseline Functional Connectivity(Baseline, immediately post-treatment, 4 weeks post-treatment)
- Change in Beck Depression Inventory (BDI)(Baseline, immediately post-treatment, 4 weeks post-treatment)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, immediate post-treatment, 4 weeks post-treatment)
- Change From Baseline Functional Connectivity Within the Default Mode Network.(Baseline, immediately post-treatment, 4 weeks post-treatment)
- Change From Baseline Functional Connectivity of Subcallosal Cingulate Cortex and the Default Mode Network.(Baseline, immediately post-treatment, 4 weeks post-treatment)
研究者
Gregory Sahlem
Clinical Assistant Professor, Department of Psychiatry & Behavioral Sciences
Stanford University