The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Depression
- 发起方
- University Hospital of North Norway
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale.
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
The present study is a randomized placebo-controlled trial examining the effect of intermittent theta burst stimulation (iTBS) on unipolar depression. iTBS is a form of transcranial magnet stimulation.
The anti-depressive effect of two weeks of once- a - day neuronavigated iTBS over the dorsolateral left prefrontal cortex (DLPFC) will be investigated in comparison to sham (placebo) iTBS. Previous studies have shown that iTBS is an effective treatment for reducing symptoms of depression, but it is still unclear why some patients have a strong response to iTBS, whereas others show less or no reduction to test possible factors that can explain the inter-individual response to iTBS.
Measures of cognitive functions, structural and functional brain data measured by Magnetic Resonance imaging (MRi), quality of life, sleep quality, general health status, and genetic measures will be obtained to answer the goals of this study.
The main hypotheses are: 1) Patients receiving iTBS will display significantly larger reductions in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale and Becks Depression Inventory II compared to patients receiving sham stimulation. 2) Reduction in depressive symptoms will be significantly associated with a concomitant improvement in executive functions measured by neuropsychological tests. 3) Stronger connectivity at baseline between the DLFPC and the anterior cingulate cortices will be associated with better response to iTBS. 4) Variability in genetic measures will be significantly associated with treatment response to iTBS. 5) Variability in white matter structural measures of the brain will be significantly associated with the anti-depressive response to iTBS.
Participants will be recruited prospectively, and the study performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. Four weeks after the last treatment day, the patients will be followed up by phone interviews.
研究者
入排标准
入选标准
- •A MADRS score of =/ \> 20 (moderate depression).
- •The current depressive episode must have lasted more than 2 weeks but less than 2 years
- •Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS and is to be kept stable throughout the study until 4 weeks after the last day of iTBS treatment.
- •Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI.
排除标准
- •The current depressive episode is in the mild range or contrary that the current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy.
- •The current depressive episode is clearly triggered by grief or a recent major stressful life event.
- •Bipolar disorder.
- •Borderline personality disorder.
- •Psychotic symptoms the last 6 months.
- •Alcohol or substance abuse/addiction in the last 6 months.
- •Current eating disorders.
- •Obsessive- compulsive disorders.
- •Post-traumatic stress disorder.
- •Any medical history of seizure.
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale.
时间窗: Up to 4 months.
Clinician rated depression inventory.
Beck's Depression Inventory - II.
时间窗: Up to 4 months.
Patient reported depression inventory.
次要结局
- Wisconsin Card Sorting Test.(Up to 2 weeks.)
- Delis-Kaplan Executive Function System.(Up to 2 weeks.)
- Brief-A(Up to 4 months.)
- Whodas 2.0(Up to 4 months.)
- Pittsburgh Sleep Quality Index.(Up to 4 months.)
- Beck's Anxiety Inventory.(Up to 4 months.)