Comparing efficacy of two probiotic strains as an adjunctive therapy to escitalopram in major depressive disorder at tertiary healthcare centre: A Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
研究概览
简要总结
Major Depressive Disorder (MDD) is a common psychiatric illness with significant morbidity. Emerging evidence suggests that modulation of the gut–brain axis through probiotics may have beneficial effects on depressive symptoms. This study aims to compare the efficacy and safety of two probiotic strains, Lactobacillus rhamnosus and Bacillus coagulans, as adjunctive therapy to escitalopram in adult patients (18–55 years) newly diagnosed with MDD.
This is a randomized, parallel-group, triple-blind, active-controlled clinical trial to be conducted at a tertiary care center. A total of 128 participants will be randomly allocated into two groups: one group will receive escitalopram plus Lactobacillus rhamnosus, and the other will receive escitalopram plus Bacillus coagulans, for a duration of 8 weeks.
The primary outcome will be change in Hamilton Depression Rating Scale (HAM-D) score from baseline to 8 weeks. The secondary outcome will include assessment of adverse drug reactions using the Naranjo ADR Probability Scale.
The study aims to identify the more effective probiotic strain as an adjunct to standard antidepressant therapy and evaluate its safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients newly diagnosed with major depressive disorder as per DSM-V criteria.
- •2 Sex/Age: -Either sex from 18 –55 years of age.
- •Patients willing to participate and comply with the follow-up visits and study procedures.
- •Patients who will give informed written consent.
- •HAM-D assessment score of more than 10 will be included.
排除标准
- •Patient already on any other antidepressant, antipsychotic or probiotic supplementation.
- •Past history of any substance abuse by the patient
- •Pregnant women
- •Intellectual disable and developmental delay patients
- •Patients with comorbidities like hypertension, uncontrolled diabetes, coronary artery disease, gastrointestinal disorders and any other organic disorder
- •All those who report any serious adverse drug reaction during the course of study will be treated accordingly and will be excluded from the study and will be analyzed separately.
研究者
Dr Amisha Rathee
Maharaja Agrasen Medical College, Agroha