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临床试验/NCT02048423
NCT02048423Unknown2 期

An Open Prospective Trial of IV Ketamine in Suicidal Adolescents

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
10
试验地点
1
主要终点
Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score.

研究概览

简要总结

  1. Investigate the safety and effectiveness of a single dose of IV Ketamine for adolescents with suicidal ideation and depression. It is hypothesize that Ketamine will be well tolerated and significantly reduce depressive symptoms and suicidal ideation.
  2. Explore whether decision making as measured by the Iowa Gambling Task changes before and after Ketamine infusion. It is hypothesize that IV Ketamine infusion will significantly improve the decision making ability a measured by the Iowa Gambling Task in adolescents that are suicidal.

详细描述

This is an open prospective study of a single, low dose (0.5 mg/kg) intravenous (IV) Ketamine in 10 adolescent subjects admitted to Nationwide Childrens Hospital following a serious suicide attempt and who meet criteria for major depression or bipolar disorder I, current episode depressed. Subjects will be recruited via the psychiatry consult service, evaluated on the floor and if eligible and consent is obtained, transferred to the PACU for IV Ketamine infusion. Following infusion and when PACU discharge criteria are met, subjects will be transferred back to their floor for medical and psychiatric monitoring until they can be transferred to an inpatient psychiatric unit for additional care. Subjects will be transferred to an inpatient psychiatric unit for continued psychiatric care as part of their routine psychiatric care via the consult team. The research team will follow-up by telephone one week and four weeks after Ketamine injection to collect additional information about the patient's overall course and response.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ketamine

Experimental

Drug

干预措施: Ketamine (Drug)

结局指标

主要结局

Change in Quick Inventory of Depression Clinician (QIDS-C) total scores from baseline to endpoint and Clinical Global Improvement Score.

时间窗: 2 days

次要结局

  • Clinical Global Assessment Scale(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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