A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 10
- 主要终点
- Mean Percent Change From Baseline in MADRS Score
研究概览
简要总结
To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.
详细描述
The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (non-pregnant) age is 21-70 years;
- •Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision, 2000 (DSM-IV-TR) criteria derived from the Mini International Neuropsychiatric Interview (MINI);
- •First episode onset before age 45;
- •Current episode > 12 month duration;
- •In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories;
- •In adult lifetime (>21 year of age) have experience a period of wellness as defined by DSM IV criteria;
- •MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists;
- •Global Assessment of Functioning (GAF) score <50;
- •Mini-mental state examination (MMSE) score >24;
- •No change in current antidepressant medication regimen or medication free for at least 4 weeks prior to study entry;
- •Able to give informed consent in accordance with institutional policies;
排除标准
- •A diagnosis of bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
- •Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, preferably screened via Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) at Baseline visit (optional);
- •In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
结局指标
主要结局
Mean Percent Change From Baseline in MADRS Score
时间窗: 4, 7, 10 and 13 months
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.
次要结局
- Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score(4, 7, 10 and 13 months)
- Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score(4, 7, 10 and 13 month)
- Responder Rate (40% Reduction in MADRS)(4, 7, 10 and 13 months)
- Mean Percent Change From Baseline in GAF Score(4, 7, 10 and 13 months)
- Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score(4, 7, 10 and 13 months)
- Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness(4, 7, 10 and 13 months)
- Mean Total CGI for Global Improvement Score(4, 7, 10 and 13 months)
- Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness(4, 7, 10 and 13 months)
- Mean Total PGI for Global Improvement Score(4, 7, 10 and 13 months)