Intranasal (IN) Ketamine in Treatment-Resistant Depression (TRD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The objective of the current study is to investigate the safety and efficacy of a single dose of intranasal (IN) ketamine in treatment-resistant depression (TRD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 21-65 years;
- •Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study;
- •Primary diagnosis of major depressive disorder as assessed by the SCID-P;
- •Current depressive episode;
- •History of a failure to respond to at least one (1) adequate pharmacotherapy trials in the current major depressive episode;
- •Subjects must have scored ≥ 30 on the IDS-C30 at Screening ≥ 24 at Treatment Day #1 and #2;
- •Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document;
- •Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.
排除标准
- •Women who plan to become pregnant, are pregnant or are breast-feeding;
- •Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
- •Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
- •Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
- •Drug or alcohol abuse or dependence within the preceding 6 months;
- •Lifetime abuse or dependence on ketamine or phencyclidine;
- •Patients judged by study investigator to be at high risk for suicide.
- •Previous participation in a ketamine study at Mount Sinai
研究组 & 干预措施
Ketamine
Subjects randomized to this arm will receive the active study medication, intranasal ketamine.
干预措施: Ketamine (Drug)
Placebo
Subjects randomized to this arm will receive intranasal saline.
干预措施: placebo (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 24 hours
Number of patients meeting response criteria of \>=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.
次要结局
- Systematic Assessment for Treatment Emergent Effects (SAFTEE)(2 weeks)
研究者
James Murrough
Principal Investigator
Icahn School of Medicine at Mount Sinai