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临床试验/NCT06060210
NCT06060210已完成4 期

Impact of Ketamine On Depressive Symptoms In Patients Undergoing Lumbo-peritoneal Shunt Insertion. A Randomized Double-blind Controlled Trial.

Benha University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年10月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
110
试验地点
2
主要终点
the rate of response to treating postoperative depression

研究概览

简要总结

Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations .

High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .

详细描述

Postoperative depression is a perioperative psychological complication that severely affects patient recovery and quality of life. In extreme cases, it may lead to suicidal behavior. Postoperative depression can be seen in various surgical operations.

Idiopathic intracranial hypertension (IIH) is the most common cause of papilledema and is typically seen in young women with elevated body mass index. The prevalence of IIH has been increasing in recent years, in parallel with climbing rates of obesity .

High rates of anxiety and depression have been reported in cohorts of patients with IIH, though it is not clear whether there is any direct relationship. Worse outcomes in terms of disability level and symptom resolution have been observed in IIH patients who have a known co-existing psychiatric illness compared to those who do not .

The use of lumbo-peritoneal (LP) shunts has been well documented as a treatment modality for patients with idiopathic intracranial hypertension (IIH). There are a number of advantages to LP shunts when compared with other treatment modalities for IIH, such as stereotactic ventriculo-peritoneal shunts (VP) and optic nerve sheath fenestrations (ONSF). LP shunts avoid intracranial risks, such as cerebral hemorrhage, seizures, and shunt malposition.

Over the past decade, it has been provoked a single administration of ketamine elicits fast (in as little as half an hour) and sustained antidepressant effects both in human and animal models of depression. There are some potential mechanisms of antidepressant actions of ketamine. MK-801, a noncompetitive NMDA receptor antagonist, produced antidepressant-like actions in the animal model of depression . Ketamine can also increase hippocampal brain-derived neurotrophic factor levels, which may be important for producing a rapid onset of antidepressant action .A recent study found ketamine could quickly elevate mood by blocking NMDAR receptor-dependent bursting activity of the lateral habenula neurons to disinhibit downstream monoaminergic reward centers and provide a framework for developing new rapid-acting antidepressants .

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)

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients of both sex
  • with an age range from 20 to 44 years old
  • having moderate to severe depressive symptoms
  • an expected hospital stay of no less than 7 days

排除标准

  • history of epilepsy
  • major depressive disorder patients
  • drug abuse
  • history of allergy to the research drug
  • heart rate > 120 beats per minute
  • systolic blood pressure > 180 mmHg
  • heart failure
  • renal or liver dysfunction
  • patients who cannot cooperate to complete psychiatric assessments
  • pregnant or breast-feeding women
  • patients who refuse to sign informed consent.

研究组 & 干预措施

Group B

Active Comparator

50-ml volumes, and the ketamine concentration is 1 mg/ml

干预措施: Ketamine (Drug)

Group A

Placebo Comparator

50-ml volume of normal saline

干预措施: normal Saline (Drug)

结局指标

主要结局

the rate of response to treating postoperative depression

时间窗: at 3 postoperative days

defined as a relative reduction of more than 50% from the baseline 10-item MADRS score

次要结局

  • The remission rate(at 1 and 3 days after the administration of ketamine.)
  • The incidence of severe pain(within the first 48 hours postoperatively)
  • The quality of life(within 7 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Ahmed Abdel Fatah

lecturer

Benha University

研究点 (2)

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