Efficacy and safety of repeated oral ketamine in treatment resistant depression
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- A change of 50% in HAM-D score will be considered as response.
研究概览
简要总结
50 patients of depression fulfilling inclusion and exclusion criteria will be recruited from Psychiatry OPD after making the diagnosis of treatment resistant depression by Consultant Psychiatrist at JNMCH, Aliagrh. They will be assessed on a semi structured proforma which includes socio-demographic details, brief clinical history, mental status examination and physical examination. The severity of Depression will be assessed using Hamilton Depression Rating Scale. After assessment patients will be randomised into 2 groups (Group 1 and Group 2) using computer generated randomisation. Group1 will be given high dose oral ketamine (3mg/kg of body weight in 50 ml of water to gulp over 3-5 minutes) and Group2 will be given low dose oral ketamine (1mg/kg of body weight in 50 ml water to gulp over 3-5 minutes).During the procedure their vitals and any other adverse effect will be monitored for 4 hours. Ketamine will be given thrice a week for 3 weeks, then the patients will be assessed again on HAM-D at 1,3 weeks and will be followed up to 3 months. This study aims to evaluate the efficacy of repeated oral ketamine as an add on treatment in treatment resistant depression with secondary objectives of comparing the efficacy of oral Ketamine at different doses and comparing the safety and adherence to repeated oral ketamine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects who will meet the ICD 10 criteria for Major Depressive Disorder.
- •Subjects who score more than 12 (moderate to severe) on Hamilton Depression Rating Scale.
- •Subjects who got no adequate response with 2 antidepressants.
- •Subjects who will give informed consent for this study.
排除标准
- •1.Subjects who will not give informed consent for study.
- •Subjects having any contraindication to administration of ketamine.
- •Subjects having any other psychiatric or physical comorbidities.
结局指标
主要结局
A change of 50% in HAM-D score will be considered as response.
时间窗: 2 years
次要结局
- 1.To see comparative effectiveness in both groups.(2. To see the tolerability and adverse effects in both groups.)
研究者
Dr Neha Dhanda
Jawaharlal Nehru Medical College
