An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
研究概览
简要总结
Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm.
Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.
详细描述
Study 1: This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. The investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. The investigators further aim to characterize the ant-depressant effect of this protocol in order to design a larger trial.
Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. All other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- •Participants must be over the age of
- •Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum
- •Participants must have a HRSD17 greater than or equal to 14 at baseline.
排除标准
- •Participants must not be pregnant.
- •Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
- •Participants must not have current psychotic symptoms.
- •Participants must not have a history of dementia or other cognitive impairment.
- •Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
- •Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
- •Participants must not have any unstable general medical conditions.
- •Participants must not have had eclampsia during pregnancy.
研究组 & 干预措施
iTBS
accelerated iTBS to Left DLPFC
干预措施: iTBS (Device)
结局指标
主要结局
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
时间窗: 7 days
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain \>80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in \>80% of enrolled women (tolerability).
次要结局
- Anti-depressant effect(4 weeks)
研究者
Kevin Caulfield
Associate Professor
Medical University of South Carolina