A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quick Inventory of Depressive Symptomatology - Clinician Version
研究概览
简要总结
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.
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
- •Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
- •Baseline score ≥ 13 on the QIDS-C
- •Stable medication regimen (>= 4 weeks) prior to study enrolment
排除标准
- •Psychotic features in the current episode
- •Lifetime history of psychotic disorders and/or bipolar I or II disorders
- •Substance or alcohol abuse/dependence in the past 6 months
- •Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- •Uncontrolled medical disease (e.g., cardiovascular, renal)
- •Pregnancy and/or lactation
- •Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
- •Hearing loss
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Clinician Version
时间窗: Week 3
Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5.
次要结局
未报告次要终点
研究者
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute