A randomised clinical study on the effectiveness of Ketamine vs Placebo in the treatment of bipolar depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day]
研究概览
简要总结
Ketamine is a competitive glutamateNmethyl- D-aspartate receptor antagonist and it has a rapid antidepressanteffect and provides rapid relief to persons suffering from depression. Thereare numerous studies that have proven the effectiveness of ketamine in thetreatment of severe depression but there are no known studies that evaluate itseffectiveness in the treatment of bipolar depression. This randomized,controlled single-blind study hopes to find if ketamine could be used to treatbipolar depression. This study uses the benzodiazepine Midazolam, which doesnot have any antidepressant effect but can mimic the effects of ketamine, as anactive comparator in blinding the control in this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent.
- •Patients diagnosed with bipolar affective disorder current episode depression as per ICD 10 guidelines Patients started on antidepressants specifically SNRIs.
排除标准
- •Co-morbid psychiatric diagnoses such as psychosis, substance dependence Mental retardation, neurological disorders, and severe medical illness Pregnancy or breastfeeding Allergy to ketamine.
结局指标
主要结局
Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day]
时间窗: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day] | Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit.
Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit.
时间窗: Patient reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) – approximately 7th day] | Response is defined as at least a 50% improvement in Baseline HAM-D score at End of Treatment Visit. The End of Treatment Visit will occur 7th day after the Baseline Visit.
次要结局
- clinician reported response to treatment [ Time Frame: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 7th day ](Number of patients with an improvement in their Baseline CGI score at the End of Treatment Visit. The End of Treatment Visit will occur in 7th day after the Baseline Visit.)