Last updated 12 months ago

Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder

84 patients around the world

Available in Brazil

It will test, in a proof-of-concept study, the antidepressant efficacy of adjunctive administration of probiotics in bipolar depression and evaluate potential inflammatory and metabolic markers associated with response to treatment. With this objective, 84 individuals with bipolar disorder type I or type II presenting subsyndromal depressive symptoms or a major depressive episode will be recruited. The study design lasts 12 weeks and is expected to last two years.

University of Sao Paulo

1Research sites

84Patients around the world

This study is for people with

Bipolar disorder

Requirements for the patient

To 65 Years

All Gender

Medical requirements

: BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI)
Score on the Young Mania Rating Scale (YMRS) < 8
Score on the Montgomery-Asberg Depression Rating Scale (MADRS) > 8
Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks

: Pregnant or lactating women
Substance or alcohol dependence
Patients on prolonged antibiotic therapy, immunosuppressive therapies
A recent introduction of antidepressants in the last 15 days
Use of another probiotic, either in the form of food, sachets, capsules and others

Sites

Universidad Federal de São Paulo - Unifesp

Recruiting

R. Sena Madureira, 1500 - Vila Clementino, São Paulo - SP, 04021-001

SponsorUniversity of Sao Paulo

Study typeInterventional

Conditions

Bipolar disorder

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05762887