NCT01573741Unknown1 期
Department of AnesthesiologyJinling Hospital, Nanjing University School of Medicine, Nanjing, China
Shi Jinyun1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- all cause remission
研究概览
简要总结
Primary Outcome Measures:
Evaluate the changes in neuroimaging and biochemistry measures with ketamine treatment.
Secondary Outcome Measures:
Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male patients, ages 18 to 65 years with a diagnosis of MDD, currently depressed or in a current major depressive episode of BD without psychotic features will be recruited into this substudy.
- •Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
排除标准
- •Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using oher antidepressant drugs in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
- •Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- •Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
- •Clinically significant abnormal laboratory tests.
- •Subjects with clinical hypothyroidism or hyperthyroidism.
- •Subjects with one or more seizures without a clear and resolved etiology.
- •Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
- •Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score
研究组 & 干预措施
ketamine,four hours monitoring hydrochloride injection
Experimental
a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
干预措施: Ketamine (Drug)
结局指标
主要结局
all cause remission
时间窗: 7day
Evaluate the effects of ketamine on depression symptoms, manic symptoms, global change in psychiatric symptoms, and suicidal ideation by MADRS,HDRS and SSI.
次要结局
未报告次要终点
研究者
Shi Jinyun
Department of Anesthesiology, School of Medicine, Jinling Hospital, Nanjing
Jinling Hospital, China
研究点 (1)
Loading locations...
相似试验
终止
不适用
Effect of Ketamine on Neurological Activity as Measured by Electroencephalogram (EEG)Treatment-resistant DepressionNCT05095792Entheon Biomedical Corp.1
已完成
不适用
Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant DepressionMajor Depressive DisorderNCT04239963Mclean Hospital60
撤回
1 期
Intravenous Ketamine Effects on Functional NeuroanatomyDepressionNCT04205890Neurological Associates of West Los Angeles
撤回
2 期
Efficacy of Ketamine in Children With Severe Brain Injury for Brain Cell ProtectionTraumatic Brain InjuryNCT00556387University of Arkansas
已完成
3 期
KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy PainKetamineChronic Post Thoracotomy PainThoracotomyPainNeuralgiaNCT00224588Assistance Publique - Hôpitaux de Paris80