Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

Sheppard Pratt Health System

Status and phase: Invitation-only; Phase 2

Conditions: Bipolar Depression

Treatments: Biological: Inert Compound; Biological: Probiotic Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03349528

SMRI/SPHS: 2017-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic Supplement

Experimental group

Description:

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.

Treatment:

Biological: Probiotic Supplement

Inert Compound

Placebo Comparator group

Description:

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.

Treatment:

Biological: Inert Compound