NCT02037035已完成早期 1 期
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glutamate Metabolism
研究概览
简要总结
This study is looking at the mechanisms underlying the behavioral effects of ketamine in healthy and depressed individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Male or female between the ages of 21-65 years.
- •Able to provide written informed consent.
- •Able to read and write English.
排除标准
- •Personal or first-degree family member with history of mood, anxiety, or psychotic axis I DSM-IV disorders confirmed after comprehensive psychiatric evaluation.
- •Any history of serious medical or neurological illness.
- •Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.
- •Lifetime history of psychoactive substance or alcohol dependence or substance or alcohol abuse (other than nicotine or caffeine abuse), or drinking more that 5 drinks/week during the last year.
- •Abnormality on physical examination.
- •A positive pre-study (screening) urine drug screen or, at the study physician's discretion on any drug screens given before the scans.
- •Pregnant or lactating women or a positive urine pregnancy test for women of child-bearing potential at screening or prior to any imaging day.
- •Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C)
- •Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan.
- •Any history indicating learning disability, mental retardation, or attention deficit disorder.
- •Known sensitivity to ketamine.
- •Body circumference of 52 inches or greater.
- •Body weight of 280 pounds or greater.
- •History of claustrophobia.
- •Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI screening questionnaire.
- •Donation of blood in excess of 500 mL within 56 days prior to dosing.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 45/min or higher than 100/min.
- •Depression Group
- •Inclusion Criteria:
- •Male or female between the ages of 21-65 years.
- •Able to provide written informed consent.
- •Current MDD Single Episode (296.2x) or Recurrent (296.3x), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition
- •Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher at baseline and start of first 13C-MRS.
- •Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher at baseline and start of first 13C-MRS.
- •No psychotropic medications for 2 or more weeks (4 weeks for Fluoxetine) prior to first 13C-MRS.
- •Be able to understand and speak English.
- •Exclusion Criteria:
- •Patients with a history of DSM-IV-TR diagnosis of bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof, is also exclusionary.
- •First-degree family member with history of schizophrenia or any other psychotic disorder.
- •Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
- •Substance abuse or dependence during the 12 months prior to screening.
- •Any history of serious medical or neurological illness.
- •Any signs of major medical or neurological illness.
- •Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
- •A positive pre-study (screening) urine drug screen or on any drug screens given before the scans.
- •Pregnant or lactating women or a positive urine pregnancy test for women of childbearing potential at screening or prior to any imaging day.
- •Any history indicating learning disability, or mental retardation.
- •Known sensitivity to ketamine.
- •Body weight of 280 pounds or greater.
- •History of claustrophobia.
- •Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI screening questionnaire.
- •Donation of blood in excess of 500 mL within 56 days prior to dosing.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 45/min or higher than 100/min.
研究组 & 干预措施
Healthy
Experimental
Healthy participants will receive ketamine in the scan
干预措施: Ketamine (Drug)
Depressed
Experimental
Depressed participants will receive ketamine in the scan
干预措施: Ketamine (Drug)
结局指标
主要结局
Glutamate Metabolism
时间窗: 40-75 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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