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

Sheppard Pratt Health System1 site in 1 country80 target enrollmentDecember 11, 2018

ConditionsBipolar Depression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Bipolar Depression
Sponsor: Sheppard Pratt Health System
Enrollment: 80
Locations: 1
Primary Endpoint: Time to Relapse
Status: Enrolling By Invitation
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 11, 2018

End Date

March 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sheppard Pratt Health System

Responsible Party

Principal Investigator

Faith Dickerson

Principal Investigator, Stanley Research Program

Sheppard Pratt Health System

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

Outcomes

Primary Outcomes

Time to Relapse

Time Frame: Weeks 0 - 24 of study participation

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

Secondary Outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS)(Weeks 0 - 24 of study participation)
New Mood Episodes(Weeks 0 - 24 of study participation)
Hamilton Depression Rating Scale(Weeks 0 - 24 of study participation)
Young Mania Rating Scale(Weeks 0 - 24 of study participation)
Columbia-Suicide Severity Rating Scale(Weeks 0 - 24 of study participation)
Brief Psychiatric Rating Scale(Weeks 0 - 24 of study participation)