Ketamine as an adjuvant to antidepressants in moderate to severe unipolar depression: A randomised clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the onset of response and effectiveness of ketamine as an adjuvant to oral antidepressants
研究概览
简要总结
Major Depressive Disorder (MDD) is a severe condition affecting millions globally, leading to significant health and socioeconomic burdens. Conventional antidepressants and cognitive-behavioral therapies often have delayed effects and may not work for all patients. This delay is particularly problematic for those at risk of suicide. Ketamine, an NMDA-receptor antagonist, has shown rapid antidepressant effects at low doses, offering a potential breakthrough for faster relief in MDD treatment, especially in individuals with suicidal thoughts. However, there is limited research on its use alongside standard antidepressants in real-world clinical settings. The study aims to evaluate the effectiveness and onset of response of ketamine as an adjuvant therapy to oral antidepressants in moderate to severe unipolar depression. Key assessments include:
- Depression symptom improvement (using the Montgomery-Åsberg Depression Rating Scale - MADRS) 2) Suicidal intent assessment (using the Columbia-Suicide Severity Rating Scale - C-SSRS)
Sample size: 70 participants (35 per group) Design: Both groups will receive oral antidepressants, along with one group also receiveing IV ketamine therapy (4 cycles over 4 weeks, with 2 cycles per week).
Application of scales at 1st visit, after 24 hours, after 2 weeks and 4 weeks.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients in the age group of 18 to 65 years Subjects who agree to sign an informed consent document Subjects diagnosed with moderate or severe depression by a qualified psychiatrist according to ICD 10 or ICD 11 Subjects having an initial score of more than 20 on the Montgomery Asberg Depression Rating Scale Subjects with or without history of suicide attempts in current episode Subjects with or without co-morbid anxiety, panic or obsessive compulsive symptoms.
排除标准
- •Subjects of age more than 65 years Subjects with history of bipolar depression Subjects with psychotic symptoms Subjects with pre-existing cognitive impairment or mental retardation Subjects with history of hypersensitivity to ketamine Pregnant and breastfeeding women Subjects with history of substance use (except nicotine and/or caffeine).
结局指标
主要结局
To assess the onset of response and effectiveness of ketamine as an adjuvant to oral antidepressants
时间窗: Baseline, after 24 hours, 2 weeks and 4 weeks
in moderate to severe unipolar depression.
时间窗: Baseline, after 24 hours, 2 weeks and 4 weeks
次要结局
- To assess improvement in symptoms using Montgomery Asberg Depression Rating(Scale (MADRS) scores in both study groups.)
- To assess the risk of suicidal intent using Columbia- Suicide Severity Rating Scale((C-SSRS) & response to treatment in both study groups.)
研究者
Dr Shruthi Nandakumar
Shri BM Patil Medical College, Hospital and Research centre, BLDE(DU)