跳至主要内容
临床试验/CTRI/2024/06/069487
CTRI/2024/06/069487已完成2/3 期

Clinical Outcome of Probiotics as Adjuvant Antidepressant an Assessor Blinded Randomised Academic Clinical Trial

Aaryaman Chatterjee1 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10日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
To determine the clinical outcome in patients receiving only anti depressants, SSPs plus antidepressants , MSP plus anti depressant

研究概览

简要总结

:               Depression is a common debilitating illness impacting more than 280 million people worldwide. It impacts all age groups across all socioeconomic strata and has been designated as a major contributor to the global disability burden. As highlighted by the National Mental Health Survey of India 2015-16, the treatment gap for any mental morbidity stands at around 70-90%. Among those who receive treatment, approximately one-fourth of the patients fail to respond to antidepressants. Despite advances in neurosciences, no single theory can adequately explain the onset and progression of Depression. The broad consensus links MDD with impairment in neural signalling, loss of hippocampal volume, reduction in growth factors such as BDNF, loss of synaptic plasticity and cognitive functions, decline in monoamine neurohormones, and dysregulation of polyamine metabolism. In recent years, the gut microbiota has emerged as a potential player in the pathogenesis of MDD, with evidence suggesting an intricate relationship between gut bacteria and Depression.

To the best of our knowledge no studies have been done in India so far    determining the clinical outcome in patients receiving only single species probiotic and multiple species probiotic along with antidepressants and comparing  the change in levels of inflammatory markers

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Drug naive/ Relapse with a minimum of 3 months without medication Prescribed T Escitalopram.

排除标准

  • Taking Antibiotics currently or in the last 1 month History of acute or chronic inflammatory conditions Antidepressants other than Escitalopram.

结局指标

主要结局

To determine the clinical outcome in patients receiving only anti depressants, SSPs plus antidepressants , MSP plus anti depressant

时间窗: 1 MONTH

To compare effect of probiotics on each symptom dimension of Depression

时间窗: 1 MONTH

次要结局

  • Compare the change in level of inflammatory markers (CRP) after 1 month(1 MONTH)

研究者

发起方
Aaryaman Chatterjee
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Aaryaman Chatterjee

Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health

研究点 (1)

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