Clinical trial NCT03349528: Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Official title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bipolar Depression
Keywords: bipolar disorder
bipolar depression
depressive episode
probiotic supplement
probiotics
relapse prevention
rehospitalization
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Relapse
timeFrame: Weeks 0 - 24 of study participation
Secondary outcomes:
measure: New Mood Episodes
timeFrame: Weeks 0 - 24 of study participation
measure: Brief Psychiatric Rating Scale
timeFrame: Weeks 0 - 24 of study participation
measure: Young Mania Rating Scale
timeFrame: Weeks 0 - 24 of study participation
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Weeks 0 - 24 of study participation
measure: Hamilton Depression Rating Scale
timeFrame: Weeks 0 - 24 of study participation
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Weeks 0 - 24 of study participation
Other outcomes:
measure: Intestinal Inflammation
timeFrame: Baseline, Week 12, Week 24
Locations:
city: Towson
country: United States
facility: Sheppart Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppart Pratt Health System
name: Faith Dickerson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: