Evaluating Psychobiotics Combined with Antidepressants for Adults Aged 18 to 60 With Major Depressive Disorder

What this Trial Is About

Researchers are evaluating whether adding psychobiotics, a combination of Lactobacillus helveticus and Bifidobacterium longum, to standard antidepressant treatment improves symptoms in adults with major depressive disorder MDD. This randomized, double-blind, placebo-controlled trial aims to find out if psychobiotics reduce depression symptoms more than a placebo and to assess their safety when combined with antidepressants. The study focuses on adults aged 18 to 60 who have MDD and are already on stable antidepressant doses. Participants will continue taking their prescribed oral selective serotonin reuptake inhibitors SSRIs and will be randomly assigned to receive either a daily psychobiotic capsule containing specific strains of Lactobacillus helveticus and Bifidobacterium longum or a placebo capsule with no active ingredients. This treatment lasts for 6 weeks, during which participants will attend follow-up visits to monitor their progress, symptoms, side effects, and adherence. The study compares the effects of psychobiotics plus antidepressants to placebo plus antidepressants. Participants will complete depression assessments at the start, week 3, and week 6 using the Hamilton Depression Rating Scale. Researchers will monitor safety through adverse event tracking, adherence checks, and regular visits. The primary outcome is the change in depression severity from baseline to week 6. The study also evaluates tolerability, patient satisfaction, and quality of life during the 6-week treatment period.

Effect of Psychobiotics With Standard Antiddepressants in Treatment of Major Depressive Disorder