Effect Of Ketamine On Patients With Moderate To Severe Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary outcome measures will be early response and early remission to treatment by improvement in severity of depression on MADRS. Response will be a more than 50% improvement on MADRS scale.
研究概览
简要总结
Major depressive disorder (MDD) is a debilitating disease that is characterized by depressed mood, diminished interests, impaired cognitive function and vegetative symptoms It is noteworthy that half of the suicides that occur per year world-wide are associated with MDD. Recent evidence suggests that a single sub-anesthetic dose of ketamine, glutamate-modulating agent, acutely reduces depressive symptoms in approximately 70% of MDD patients 24 hours after infusion. This randomised controlled study will be conducted in Department of Psychiatry of DMC&H, Ludhiana over a period of one year on 90 patient in age group 18-65 diagnosed with Major Depressive Disorder as per InternationalClassificationofDiseases (ICD-11) taking one class of antidepressant (Escitalopram 10-20 mg ) for 4 weeks. After obtaining informed consent they will be admitted as indoor patients and further randomised into 3 groups of 30 patients each. Group A (n=30) will receive intravenous Ketamine, Group B (n=30) will receive intramuscular Ketamine and Group C (n=30) will act as control group. The identification and socio-demographic data will be recorded. The severity of depression will be assessed on Montogomery-Asberg Depression Rating Scale (MADRS). In this study therapeutic efficacy of intravenous versus intramuscular ketamine will be assessed and compared with control group . All the three groups uses escitalopram as a part of their treatment.Primary outcome measures will be early response and early remission to treatment by improvement in severity of depression on MADRS. Response will be a more than 50% improvement MADRS. Secondary outcome measure will be decrease in suicidal ideation and adverse events in CADSS.
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
- •Patient seeking treatment at the department of psychiatry, Dayanand Medical College & Hospital (DMCH), Ludhiana.
- •Both males and females aged 18-65 years.
- •Primary diagnosis of MDD without psychotic features based on DSM-
- •Diagnosis of moderate-severe MDD defined by MADRS ≥
- •Patient who are taking escitalopram 10-20 mg for at least 4 weeks.
- •Medically stable for study participation.
排除标准
- •Any other major psychiatric disorder in patients of Major Depressive Disorder.
- •History of any known uncontrolled medical condition.
- •Women who are pregnant or lactating.
- •Patient who have not given consent for the study.
- •Untreated hypertension.
结局指标
主要结局
Primary outcome measures will be early response and early remission to treatment by improvement in severity of depression on MADRS. Response will be a more than 50% improvement on MADRS scale.
时间窗: reductions in MADRS score will be measured after 4 hrs post ketamine in every session
次要结局
- Secondary outcome measure will be decrease in suicidal ideation and adverse events in CADSS(Patients will undergo prospective observation. Vitals (blood pressure, heart rate etc.,) will be monitored every 5 minutes throughout the time of infusion and every half hourly for 2 hours after infusion.he patients will be discharged after assessing them on Modified Aldrete Score.)
研究者
DR RANJIVE MAHAJAN
DMCH
