NL-OMON54601招募中3 期
Deep brain stimulation of the medial forebrain bundle for patients with treatment-resistant depression - MFB DBS for TRD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Primary diagnosis: Major Depressive Disorder
- •2) Treatment-resistance defined as inadequate response to (or intolerable side
- •effects) of all of the following:
- •a. At least 2 adequately dosed treatments of at least two 2nd generation
- •antidepressants (SSRI, SNRI, NaSSA) for a period of 6-8 weeks
- •b. An adequately dosed treatment with a tricyclic antidepressant (TCA) for 6-8
- •c. TCA + addition of lithium when tolerable at least 6 weeks at therapeutic
- •drug levels (>0.6 mmol/L))
- •d. An adequately dosed treatment with a monoamine oxidase inhibitor OR >=1
- •session of ECT, for which the series of ECT was terminated either due to
- •adverse effects or insufficient response (including at least 6 sessions of
- •bilateral ECT) OR patients who are kept stable with maintenance ECT, but who
- •relapse after discontinuation of this maintenance ECT are also eligible, but
- •need to fulfill all other inclusion criteria.
- •Besides the above defined treatments, we will evaluate the adequacy of all
- •attempted antidepressant treatments, including off-label strategies such as
- •esketamine. In case on- or off-label treatments are available to the patient,
- •but have not been tried adequately, these options are discussed with and
- •offered to the patient before offering deep brain stimulation.
- •3) HAM-D total >= 18
- •4) Illness duration > 2 years
- •5) Age: 20-75 years old
排除标准
- •1) Bipolar Disorder
- •2) Schizophrenia /history of psychosis unrelated to MDD
- •3) Alcohol or substance abuse (including benzodiazepines) during last 6 months,
- •excluding nicotine use
- •4) Primary and severe personality disorder diagnosed independently from TRD
- •5) Explicit suicidal plans requiring hospitalization in a closed ward
- •6) Contraindications to have surgery
- •7) Depression as a result of acute brain damage (e.g. stroke / hemorrhage)
- •8) Parkinson*s disease, Tourette syndrome, dementia, epilepsy, tic disorder
- •9) Pregnancy
研究者
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