Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in baseline HDRS Score
研究概览
简要总结
A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
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, Care Provider, Investigator)
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
- •Age: 18-65 years old
- •Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
- •Classification of MDD as treatment-resistant.
- •No brain structural abnormalities as evidenced by an MRI scan.
- •Signed acceptance of Informed Consent.
排除标准
- •Other psychiatric diagnosis apart from MDD.
- •Substance abuse or dependence (prior or during study).
- •Pregnancy.
- •Congestive heart disease.
- •Personal history of psychosis.
- •First-degree relative with history of psychosis.
- •Glaucoma.
- •Present neurological disease.
- •High blood or pulmonary artery pressure.
- •Declining the signing of the informed consent.
研究组 & 干预措施
Ketamine treated
干预措施: Ketamine (Drug)
Control, placebo treated
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in baseline HDRS Score
时间窗: 20 minutes before and 40 minutes after ketamine infusion.
The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.
Daily change in HDRS post-ketamine infusion.
时间窗: 1,2,3,4,5,6 and 7. Days after ketamine infusion
On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.
次要结局
- Baseline blood pressure (BP).(20 minutes before ketamine infusion.)
- Changes from baseline in blood pressure (BP)(every 5 minutes in a 300 minutes period)
研究者
Paul J. Lamothe
Chief of the Research Department, Neurological Center.
American British Cowdray Medical Center