Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression

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.

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.g., epilepsy, serious head injury, concussion involving loss of consciousness, brain tumor, or other neurological disorder)
• Pregnant, planning to become pregnant, or breastfeeding during the study period
• Documented celiac disease
• Participated in any investigational drug trial in the 30 days prior to the Visit 1/Baseline visit
• Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge