At a glance
ClinicalIndex Comparison RecordN/ACompleted· 66 enrolled
Drug / intervention
Probiotic Supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
In Brief
A clinical study evaluating Probiotic Supplement and Inert Compound for Bipolar Disorder and Schizoaffective Disorder. Completed, enrolled 66 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Schizoaffective Disorder
CountriesUnited States
CollaboratorsStanley Medical Research Institute
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionDec 2016
TodayJul 2026
First PostedNov 21, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.6 years ago
Interventions
Probiotic Supplementdietary
Probiotic Supplement 1 tablet by mouth daily
Inert Compounddietary
Probiotic identical placebo 1 tablet by mouth daily