Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Role of Ketamine as Antidepressant
研究概览
简要总结
In this study we will assess the effect of Ketamine infusion on depressive symptoms and in particular its effect on Suicidal behavior, ideation and thoughts in patients with treatment- resistant MDD.
详细描述
A Twice repetition of IV infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant MDD
The work aims to:
- To assess the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder.
- To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The Sequentially Numbered, Opaque, Sealed Envelope technique (Schulz and Grimes, 2002) was employed: the randomization group was listed on paper and preserved in an opaque sealed envelope with a serial number. When a patient agreed to participate, the pharmacy (care provider) opened the sealed envelope and assigned the patient to the appropriate treatment group on the morning of their first infusion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling diagnostic criteria of treatment-resistant MDD.
- •Presence of suicidal risk.
- •No comorbid medical or neurological conditions.
- •Age above 18 years old.
- •Both gender.
- •Informed written consent from the patient or his legitimate.
排除标准
- •Presence of perceptual disturbance.
- •History of sensitivity to ketamine.
- •Refusal to participate in the study.
研究组 & 干预措施
Ketamine group
This group had ketamine
干预措施: Ketamine (Drug)
结局指标
主要结局
Role of Ketamine as Antidepressant
时间窗: 1 year
the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder.
Effect of Ketamine on Suicidality
时间窗: 1 year
finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients
次要结局
未报告次要终点
研究者
G.A. Khedr
Role Of Ketamine in treatment-Resistant Major Depressive Disorder And its Effect on Suicidality.
Assiut University