Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression (NCT03349528) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
United States80 participantsStarted 2018-12-11
Plain-language summary
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-65 (inclusive)
* Capacity for written informed consent
* Currently (or within the last 3 weeks) admitted to a Sheppard Pratt inpatient or day hospital program for symptoms of a depressive episode and a diagnosis Bipolar Disorder I or II, most recent episode depressed per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), the diagnosis of which is confirmed with the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
* Proficient in the English language
* Available to come to Sheppard Pratt Towson for study visits after hospital discharge
Exclusion Criteria:
* Depressive symptoms better accounted for by a diagnosis of Major Depressive Disorder, Schizoaffective disorder, Schizophrenia, or disorder(s) other than Bipolar Disorder I or II
* DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the DSM
* Substance- or medically-induced mood symptoms at time of Visit 1/Baseline visit
* DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within three months prior to the Visit 1/Baseline visit
* History of IV drug use
* Any clinically significant or poorly controlled medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition, uncontrolled diabetes, congestive heart failure)
* A serious medical condition that affects brain or cognitive functioning (e…