DRKS00014947招募中未知
Controlled Randomized Clinical Trial to assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients with Treatment Resistant Major Depression - FORESEE III
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Patients eligible for inclusion in this trial must meet all of the following criteria:
- •1)Major depression (MD), severe, unipolar, or bipolar in an acute depression episode.
- •2)German mother tongue or fluent.
- •3)Male or female patients =20 and =75 years.
- •4)Hamilton Depression Rating Scale (HDRS-28) score of >21.
- •5)Global Assessment of Function (GAF) score of <45.
- •6)At least 4 episodes of depression or one chronic episode >2 years.
- •7)Failure to respond to
- •a.adequate trials of primary antidepressants from at least 3 different classes (>5 weeks at the maximum recommended or tolerated dose) and
- •b.adequate trials of augmentation/combination of a primary antidepressant (>3 weeks at the usually recommended or maximum tolerated dose) using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) and
- •c.an adequate trial of electroconvulsive therapy (ECT) (>6 treatments) and an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
- •8)Able to give written informed consent.
- •9)Compliance to participate in the study.
- •10)Drug free or on stable drug regimen at least 6 weeks before study entry.
排除标准
- •1)Current or past non-affective psychotic disorder.
- •2)Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
- •3)Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI), any contraindications to perform a planned MRI to visualize the slMFB.
- •4)Any surgical contraindications to undergoing DBS like deformed or displaced or not discernable target region, scarring after brain disease (infarction), need for continuous anticoagulation that cannot be bridged in order to obtain normal coagulation, present risks for anesthesia or any brain or scalp injury (even after intracranial surgery).
- •5)Current or unstably remitted substance abuse (aside from nicotine).
- •6)Pregnancy, women of childbearing age not using effective contraception and breast feeding women.
- •7)History of severe personality disorder.
- •8)Acute suicidal ideation.
- •9)Patients with advanced stage cardiovascular disease.
- •10)Patients under immunosuppressive or chemo therapy because of malignant disease.
- •11)Patients who had previous intracranial surgery.
- •12)Patients who are currently under DBS therapy or have implanted any kind of stimulator already.
- •13)Patients with aneurysm clips.
- •14)Patients with cochlear implants.
- •15)Patients with planned diathermy.
- •16)Persons who are in a relationship of dependence/employment with the sponsor or the investigator.
- •17)Simultaneous participation or previous participation within 30 days prior to start of screening in a clinical trial involving investigational medicinal product(s) or investigational medical device(s).
研究者
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