Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
NCT ID: NCT03349528
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-12-11
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic Supplement
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.
Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily
Inert Compound
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.
Inert Compound
Probiotic identical placebo 1 tablet by mouth daily
Interventions
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Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily
Inert Compound
Probiotic identical placebo 1 tablet by mouth daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Sheppard Pratt Health System
OTHER
Responsible Party
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Faith Dickerson
Principal Investigator, Stanley Research Program
Principal Investigators
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Faith Dickerson, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Sheppart Pratt Health System
Locations
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Sheppart Pratt Health System
Towson, Maryland, United States
Countries
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Other Identifiers
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SMRI/SPHS: 2017-01
Identifier Type: -
Identifier Source: org_study_id
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