Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

NCT03349528 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SMRI/SPHS: 2017-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Depression

Keywords

bipolar disorder; bipolar depression; depressive episode; probiotic supplement; probiotics; relapse prevention; rehospitalization

Outcome Measures

Primary Outcomes (1)

• Time to Relapse

  Time to relapse defined as time until psychiatric rehospitalization during the study period

  Weeks 0 - 24 of study participation

Secondary Outcomes (6)

• New Mood Episodes

  Weeks 0 - 24 of study participation

• Brief Psychiatric Rating Scale

  Weeks 0 - 24 of study participation

• Young Mania Rating Scale

  Weeks 0 - 24 of study participation

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  Weeks 0 - 24 of study participation

• Hamilton Depression Rating Scale

  Weeks 0 - 24 of study participation

Other Outcomes (1)

• Intestinal Inflammation

  Baseline, Week 12, Week 24

Study Arms (2)

Probiotic Supplement

EXPERIMENTAL

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.

Biological: Probiotic Supplement

Inert Compound

PLACEBO COMPARATOR

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.

Biological: Inert Compound

Interventions

Probiotic Supplement BIOLOGICAL

Probiotic supplement 1 tablet by mouth daily

Also known as: Probio-Tec® BG-VCap-6.5

Probiotic Supplement

Inert Compound BIOLOGICAL

Probiotic identical placebo 1 tablet by mouth daily

Inert Compound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheppard Pratt Health System: lead

Study Sites (1)

Sheppart Pratt Health System

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Faith Dickerson, PhD, MPH

  Sheppart Pratt Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Stanley Research Program

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 21, 2017
• Study Start: December 11, 2018
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)