Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline
研究概览
简要总结
The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
- •MADRS score > 20
- •Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.
排除标准
- •Active or past psychotic disorder, including a history of psychotic affective state
- •Mental Retardation or Autistic Spectrum Disorder
- •Prominent personality disorder
- •Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition.
- •Chronic nasal congestion
- •Active or recent drug or alcohol abuse
- •Substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission.
研究组 & 干预措施
Active IV
Will receive IV Ketamine, along with IN placebo.
干预措施: Ketamine (1st phase) (Drug)
Active IV
Will receive IV Ketamine, along with IN placebo.
干预措施: Placebo (Drug)
Active IV
Will receive IV Ketamine, along with IN placebo.
干预措施: Ketamine (2st phase) (Drug)
Active IN
Will receive IN Ketamine, along with IV placebo.
干预措施: Placebo (Drug)
Active IN
Will receive IN Ketamine, along with IV placebo.
干预措施: Ketamine (1st phase) (Drug)
Active IN
Will receive IN Ketamine, along with IV placebo.
干预措施: Ketamine (2st phase) (Drug)
结局指标
主要结局
MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline
时间窗: 15 weeks
次要结局
- Tolerability of Route, based on side effects questionnaire(3 weeks)
- Ratio of subjects achieving Response(15 weeks)
- Durability of anti-depressant effect according to MADRS Score(15 weeks)
- Ratio of subjects achieving remission(15 weeks)
研究者
Aviv Segev
Head, Psychiatric Emergency Services
Shalvata Mental Health Center