A clinical trial to study the effect of Probiotics in patients with Major Depressive Disorder

Phase 4

Completed

• Conditions: Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

• Registration Number: CTRI/2020/05/025027
• Lead Sponsor: Deepika Bansal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. The patients with a diagnosis of Major Depressive Disorder according to DSM-5 criteria presenting to Department of Psychiatry in DMC&H, Ludhiana.

2. Age group between 18-65 years.

3. Patients who have agreed upon no changes in their routine physical activity and dietary intake throughout the study.

Exclusion Criteria

1.Any other major psychiatric disorder in patients of Major Depressive Disorder.

2.Regular intake of probiotics during last 2 months before recruitment for the study.

3.History of any renal, hepatic, cardiovascular or respiratory disease in the patient.

4.Intake of antioxidant or omega 3 supplements less than 6weeks before beginning of study.

5.Female patients currently having pregnancy and lactation.

6.Any type of substance abuse in the patient.

7.Patients with history of heart attack and stroke following a specific diet.

8.Patients with intake of antibiotics 2 weeks before the study or during study.

9.Immunocompromised patients.

10.Patients who have not given consent for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.Timepoint: In this study, the primary outcome will be assessed on Mini International Neuropsychiatric Interview (M.I.N.I.), Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale(MADRS). Depressed mood will be judged in the beginning at 0 week, after 3 weeks and at the end of study at 6 weeks and the scores will be compared.

Secondary Outcome Measures

Name	Time	Method
study of adverse drug reactionsTimepoint: 0,3,6 weeks