Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale - 28 items
研究概览
简要总结
Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. Scopolamine infusions produced also a significant improvement in depression that was sustained over time.
We therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.
详细描述
Patients will undergo two weeks of prospective observation, they will then receive IV infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. The schedule of administration will be twice a week of three weeks. After this phase the subject will be followed with assessments every two weeks for three months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Outpatients with sever treatment-resistant depression
- •Currently depressed
- •Currently under regular psychiatric care
- •On an aggressive antidepressant regimen, stable for 4 weeks
排除标准
- •No history of other major psychiatric illnesses, including bipolar disorder
- •No history of psychosis
- •No history of drug abuse
- •No major medical illness or unstable medical condition.
研究组 & 干预措施
Ketamine plus placebo
Subjects assigned to this paradigm will receive a 15 minute infusion of normal saline (placebo) followed by IV ketamine at 0.25mg/kg over 45 minutes twice a week for 3 weeks.
干预措施: Ketamine (Drug)
Scopolamine plus placebo
Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).
干预措施: Scopolamine (Drug)
Ketamine plus scopolamine
Subject will receive an IV scopolamine infusion at a dose of 2ug/kg over 15 minutes, followed by an IV infusion of ketamine at a dose of 0.25mg/kg over 45 minutes.
干预措施: Ketamine (Drug)
Ketamine plus scopolamine
Subject will receive an IV scopolamine infusion at a dose of 2ug/kg over 15 minutes, followed by an IV infusion of ketamine at a dose of 0.25mg/kg over 45 minutes.
干预措施: Scopolamine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale - 28 items
时间窗: up to 4 months
Subjects will be assessed with HAMD-28
次要结局
- Systematic Assessment for Treatment Emergent Events (SAFTEE)(up to 4 months)
研究者
Cristina Cusin, MD
Instructor HMS
Massachusetts General Hospital