Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS) score
研究概览
简要总结
Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.
详细描述
population: inclusion criteria:
-
Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.
-
Montgomery Asberg Depression Rating Scale (MADRS) score 20-60
-
TMS safe exclusion criteria:
-
Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or Electro Convulsive Treatment (ECT) <2 months before inclusion
ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5 Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self Rating (QIDS-SR) baseline, weekly, last visit
condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40 min, C). 20 treatment sessions/subject. 10 subjects in each group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •see above
排除标准
- •see above
研究组 & 干预措施
A
dTMS standard protocol 10 min session
干预措施: dTMS (Device)
B
dTMS standard protocol 20 min session
干预措施: dTMS (Device)
C
dTMS standard protocol 40 min session
干预措施: dTMS (Device)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS) score
时间窗: baseline to last visit (treatment session 20, an average of four weeks)
MADRS baseline - MADRS last visit (treatment session 20)
次要结局
- Clinical Global Impression Severity (CGI-S)(baseline to last visit (treatment session 20, an average of four weeks))
- Montgomery Asberg Depression Rating Scale (MADRS) remission(last visit (treatment session 20, an average of four weeks))
- memory objective(baseline to last visit (treatment session 20, an average of four weeks))
- memory subjective(last visit (treatment session 20, an average of four weeks))
- Montgomery Asberg Depression Rating Scale (MADRS) response(last visit (treatment session 20, an average of four weeks))
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](baseline to last visit (treatment session 20, an average of four weeks))
研究者
Johan Lundberg
Section head, associate professor, MD PhD
Section for Affective Disorders; Northern Stockholm Psychiatry