跳至主要内容
临床试验/CTRI/2024/07/070304
CTRI/2024/07/070304招募中不适用

Effect Of Ketamine On Patients With Moderate To Severe Depressive Disorder

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月20日最近更新:

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

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR RANJIVE MAHAJAN

DMCH

研究点 (1)

Loading locations...

相似试验