Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Status: | Recruiting |
---|---|
Conditions: | Depression, Depression, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/20/2019 |
Start Date: | December 11, 2018 |
End Date: | December 2020 |
Contact: | Cassie Stallings, RNC, MA |
Email: | cstallings@sheppardpratt.org |
Phone: | 410-938-3000 |
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression
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.
will reduce relapse and improve the clinical course among participants who have been
hospitalized for bipolar depression.
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
We found this trial at
1
site
6501 North Charles Street
Towson, Maryland 21204
Towson, Maryland 21204
Principal Investigator: Faith Dickerson, PhD, MPH
Phone: 410-938-3000
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