The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Probiotic Supplement 1 tablet by mouth daily
Probiotic identical placebo 1 tablet by mouth daily
Sheppard Pratt Health System
Baltimore, Maryland, United States
Time to First Rehospitalization
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Time frame: Weeks 0 - 24 of study participation
Number of Participants Rehospitalized
This is a count of the participants who had at least one rehospitalization during the study period.
Time frame: Weeks 0 - 24 of study participation
Total Number of Rehospitalizations
This is a count of the number of rehospitalizations in each group during the study period.
Time frame: Weeks 0 - 24 of study participation
Mean Days Rehospitalized
This is the mean number of days rehospitalized for participants in each group during the study period.
Time frame: Weeks 0 - 24 of study participation
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