Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE: FOREbrain Stimulation dEprEssion)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
研究概览
简要总结
The investigators will investigate in a sham controlled design antidepressant effects and safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).
详细描述
The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).
The exact stimulation coordinates are:
MNI152 coordinates:
left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9
MCP coordinates:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression (MD), severe, unipolar type
- •German mother tongue
- •Hamilton Depression Rating Scale (HDRS24) score of > 20
- •Global Assessment of Function (GAF) score of < 45
- •At least 4 episodes of MD or chronic episode > 2 years
- •> 5 years after first episode of MD
- •Failure to respond to
- •adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
- •adequate trials (>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant);
- •an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and;
- •an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
- •Able to give written informed consent
- •No medical comorbidity
- •Drug free or on stable drug regimen at least 6 weeks before study entry
排除标准
- •Current or past nonaffective psychotic disorder
- •Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- •Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- •Any surgical contraindications to undergoing DBS
- •Current or unstably remitted substance abuse (aside from nicotine)
- •Pregnancy and women of childbearing age not using effective contraception
- •History of severe personality disorder
研究组 & 干预措施
Sham then Stimulation
干预措施: DBS (Device)
Sham then Stimulation
干预措施: No Stimulation (Sham) (Device)
Stimulation then Sham
干预措施: DBS (Device)
Stimulation then Sham
干预措施: No Stimulation (Sham) (Device)
结局指标
主要结局
Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
时间窗: 12 month after DBS stimulation onset
Change in MADRS after 12 months as compared to mean baseline score. MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It is used as an adjunct to the Hamilton Rating Scale for Depression (HAMD) and more sensitive to the changes in depression than the Hamilton Scale is. MADRS will be rated 3 times for baseline assessment, weekly during parameter optimization and monthly during follow-up. Reduction compared to baseline will be assessed after 12 months of DBS.
次要结局
- Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)(12 month after DBS stimulation onset)
- Adverse Event Schedule(12 month after DBS stimulation onset)
- Comprehensive neuropsychological test battery(12 month after DBS stimulation onset)
研究者
Thomas E. Schlaepfer, MD
Professor of Psychiatry and Psychotherapy
University Hospital, Bonn