Last updated: December 1, 2023
Sponsor: University of Sao Paulo
Overall Status: Active - Recruiting
Phase
N/A
Condition
Bipolar Disorder
Mood Disorders
Treatment
Placebo Group
Probiotic Group
Clinical Study ID
NCT05762887
U1111-1280-7625
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- BD type I or type II, according to the use of Mini Internacional NeuropsychiatricInterview (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 4weeks
Exclusion
Exclusion Criteria:
- 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
Study Design
Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Placebo Group
Phase:
Study Start date:
January 09, 2023
Estimated Completion Date:
December 30, 2024
Study Description
Connect with a study center
University of Sao Paulo
São Paulo, Sao Paulo 05403010
BrazilActive - Recruiting
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