Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Bipolar Depression
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring bipolar disorder, bipolar depression, depressive episode, probiotic supplement, probiotics, relapse prevention, rehospitalization
Eligibility Criteria
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
Sites / Locations
- Sheppart Pratt Health System
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Probiotic Supplement
Inert Compound
The probiotic supplement will consist of capsules containing approximately 1 billion (1.0 x 10^9) colony forming units of the probiotic organisms, Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis subsp. lactis BB-12® (BB-12®). The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. Participants will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.