Efficacy of probiotics in elderly patients with depression: A randomized placebo-controlled trial
Not Applicable
- Conditions
- Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
- Registration Number
- CTRI/2024/01/061173
- Lead Sponsor
- Department of Health Research, Ministry of Health and Family Welfare, Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Elderly (=60 years) patients of both gender.
2. Patients with a present episode (=2 weeks) of moderate unipolar depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score, 20–34].
3. Patients who had not received any treatment for the present episode of depression.
Exclusion Criteria
1. Patients who had taken a single dose of any antibiotic within the past 1 month.
2. Patients with psychosis or those with a severe suicidal tendency (according to Beck Scale for Suicidal Ideation).
3. Patients with a cognitive deficit [Montreal Cognitive Assessment (MoCA) score of <25], delirium, Parkinson’s disease, or hearing difficulties.
4. Patients with diagnosed irritable bowel syndrome or any absorption disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To compare the response rates at 12 weeks (proportion of patients achieving =50% reduction in the MADRS (Montgomery-Åsberg Depression Rating Scale) score from the corresponding scores at baseline) between the two groups.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method •To compare the dosage of background antidepressants between the two groups at 12 weeks.Timepoint: 6, 12 & 24 weeks