Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of severity and impact of insomnia before and after treatment
研究概览
简要总结
The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression
详细描述
We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18_65 years
- •Sex:male and female
- •Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5
- •No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle
- •Pharmacological resistance
排除标准
- •Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder
- •Patients complaining of epilepsy
- •pregnancy and breastfeeding
- •peacemaker spinal or bladder stimulator
- •History of skull surgery and trauma
- •presence of metallic foreign body
结局指标
主要结局
Comparison of severity and impact of insomnia before and after treatment
时间窗: One year for completion of the study
We will use Insomnia Severity Index scale.\_Insomnia Severity Index:assess the nature, severity and impact of insomnia,0\_7(absence insomnia) 8\_14(subthreshold insomnia)15\_21(moderate insomnia)22\_28(severe insomnia)
Comparison of severity of manic symptoms before and after treatment
时间窗: One year for completion of the study
We will use Young Mania Rating Scale.\_Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\<=12(remission)13\_19(minimal symptoms)20\_25(mild mania)26\_37(moderate mania)38\_60 severe mania
Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.
时间窗: One year for completion of the study
We will use Clinical Global Impression Severity Scale.\_Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill
Comparison of depressive symptoms before and after treatment
时间窗: One year for completion of the study
We will use Hamilton Depression Rating Scale.\_Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0\_7(normal range)8\_16(mild severity)17\_23(moderate severity)\>23(severe depression)
次要结局
未报告次要终点