Status:
UNKNOWN
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Lead Sponsor:
Sheppard Pratt Health System
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 bipola...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03349528
Start Date
December 11 2018
End Date
March 1 2025
Last Update
April 21 2023
Active Locations (1)
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1
Sheppart Pratt Health System
Towson, Maryland, United States, 21204