A Randomized Trial Comparing the Effectiveness and Tolerability of High and Low Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression: An Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high) frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 to 70 years
- •Current major depressive episode (MDE) in the context of a bipolar disorder type I or II (according to the DSM-IV-TR) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration)
- •Baseline score ≥ 13 on the Quick Inventory of Depressive Symptomatology - Clinician-Administered (QIDS-C), i.e., a MDE of at least moderate intensity
排除标准
- •Psychotic features in the current episode
- •Lifetime history of a non-mood-related psychotic disorder
- •Substance or alcohol abuse/dependence in the past 6 months
- •Unstable medical disease (e.g., cardiovascular, renal)
- •Presence of mood cycles of < 30 days duration
- •Pregnancy and/or lactation
- •Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant)
- •Hearing loss
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Week 5
Pre-post neuromodulation treatment reduction on the scores of the MADRS
次要结局
- Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)(Week 5)
- 21-item Hamilton Depression Rating Scale (HAM-D21)(Week 5)
- Montogmery-Asberg Depression Rating Scale (MADRS)(Week 5)
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(Week 5)
研究者
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute