Bipolar Depression
Conditions
Keywords
bipolar disorder, bipolar depression, depressive episode, probiotic supplement, probiotics, relapse prevention, rehospitalization
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.
Interventions
BIOLOGICALProbiotic Supplement
Probiotic supplement 1 tablet by mouth daily
BIOLOGICALInert Compound
Probiotic identical placebo 1 tablet by mouth daily
Sponsors
Sheppard Pratt Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse | Weeks 0 - 24 of study participation | Time to relapse defined as time until psychiatric rehospitalization during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Mood Episodes | Weeks 0 - 24 of study participation | Number of new mood episodes determined by Structured Clinical Interview for DSM-5 Disorders (SCID-5), an interview using criteria from the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) |
| Brief Psychiatric Rating Scale | Weeks 0 - 24 of study participation | The Brief Psychiatric Rating Scale (BPRS) will be used to measure the severity of psychiatric symptoms. The BPRS contains 24 items, each rated on a scale from 1 (not present) to 7 (very severe). Total scores range from 24 to 168, and high scores indicate increased symptomatology. |
| Young Mania Rating Scale | Weeks 0 - 24 of study participation | The Young Mania Rating Scale (YMRS) will be used to measure mania-related symptoms. The YMRS contains 11 items, each rated either on a scale from 0 to 4 or a scale from 0 to 8. Total scores range from 0 to 60, and higher scores indicate increased mania-related symptomatology. |
| Hamilton Depression Rating Scale | Weeks 0 - 24 of study participation | The Hamilton Depression Rating Scale (HAM-D) will be used to measure depression-related symptoms. The HAM-D contains 24 items, each rated either on a scale from 0 to 2 or on a scale from 0 to 4. Total scores range from 0 to 76, and higher scores indicate increased depression-related symptomatology. |
| Columbia-Suicide Severity Rating Scale | Weeks 0 - 24 of study participation | The Columbia-Suicide Severity Rating Scale (C-SSRS) measures suicide attempts and ideation. The C-SSRS is a tool containing one section of items used for assessing the specific type and intensity of suicidal ideation and one section of items used to determine number and type of suicide attempts and actual or potential lethality of the most lethal suicide attempt. The number of items used depends upon participant responses, and higher ratings on specific items indicate either more attempts, more intense ideation, or more lethal behavior. The C-SSRS will be used to determine the occurrence of suicide attempts or ideation. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) | Weeks 0 - 24 of study participation | The Montgomery-Åsberg Depression Rating Scale (MADRS) will be used to measure depression-related symptoms. The MADRS contains 10 items, each rated on a scale from 0 (none or normal) to 6 (most severe). Total scores range from 0 to 60, and higher scores indicate increased depression-related symptomatology. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Inflammation | Baseline, Week 12, Week 24 | Levels of intestinal inflammation as measured by antibodies to casein, gliadin and saccharomyces cerevisiae as well as C-reactive protein (CRP) and cytokines |
Countries
United States
Outcome results
None listed