Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: Probiotic capsule containing 120 million spores of lactic acid bacillus: Probiotic capsule containing 120 million spores of lactic acid bacillus will be given once daily in the morning
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
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
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. Patient not willing to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in depression symptoms as assessed by Hamilton Depression Rating Scale (HAMD-17)Timepoint: 0 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in serum IDO and serum BDNF after 6 weeks of add-on probiotic therapy. To evaluate the change in cognition score and the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of add-on probiotic therapy. To evaluate the safety of add-on probiotic therapy.Timepoint: 0 AND 6 WEEKS | — |
Countries
India
Contacts
Public ContactArun P Sunder
All India Institute of Medical Sciences New Delhi
Outcome results
None listed