Effect of Probiotics as an Addon to Standard Antidepressant Therapy in Patients of Major Depressive Disorder in Indian population A Randomized Double Blind Placebo Controlled Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- All India Institute of Medical Sciences New Delhi
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Reduction in depression symptoms as assessed by Hamilton Depression Rating Scale (HAMD-17)
Overview
Brief Summary
This study will use a prospective, randomized, double-blind, placebo-controlled design to investigate the effects of probiotic (lactic acid bacillus) supplementation over 6 weeks on patients with major depressive disorder (MDD). The primary aim is to assess changes in depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17). Secondary objectives include evaluating changes in serum IDO and serum BDNF levels, cognitive scores, and the Montgomery-Ã…sberg Depression Rating Scale (MADRS), as well as assessing the safety of the supplementation.
Participants will be clinically diagnosed with major depressive disorder and must have been on stable antidepressant therapy for at least the past 4 weeks. They will be screened in the psychiatry outpatient department at AIIMS, New Delhi. Eligible participants meeting the inclusion criteria will be randomly assigned to either the treatment group, receiving probiotic (lactic acid bacillus) supplementation, or the placebo group, receiving a matching placebo. Both groups will continue their ongoing antidepressant regimen for 6 weeks.
At enrollment, demographic data, depression scores, and antidepressant treatment-related data will be collected. Blood samples will be taken to measure depression-related markers (BDNF and IDO). After 6 weeks of supplementation, all baseline parameters will be reassessed. Changes in depression scores from baseline to post-supplementation will be calculated and presented as mean (SD). Any adverse events during the intervention will be monitored and reported to the corresponding authorities.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All adult patients of either sex aged 18-65 years with clinical diagnosis of Major Depressive Disorder as per DSM-5 criteria.
- •Patients on stable dose (no change in dose) of anti-depressants for 4 weeks.
- •Patients willing to participate and give consent.
Exclusion Criteria
- •Patients with comorbid psychiatric or neurological disorders and substance use disorder except nicotine replacement therapy Patient currently having suicidal ideas or history of suicidal plan/attempt.
- •Patients who have taken antibiotics in the last 4 weeks, are currently on antibiotics, or need to take antibiotics during the study period Pregnancy or lactation or expecting to get pregnant during the treatment.
- •Patient on concomitant warfarin, antiplatelets, chemotherapy for oncologic conditions, steroids, having autoimmune diseases, immunocompromised patients, short-gut syndrome.
- •Patients with chronic liver disease.
Outcomes
Primary Outcomes
Reduction in depression symptoms as assessed by Hamilton Depression Rating Scale (HAMD-17)
Time Frame: 0 and 6 weeks
Secondary Outcomes
- To evaluate the change in serum IDO and serum BDNF after 6 weeks of add-on(probiotic therapy.)
Investigators
Arun P Sunder
All India Institute of Medical Sciences New Delhi