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

Use our guide to learn which trials are right for you!

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.


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
Principal Investigator: Faith Dickerson, PhD, MPH
Phone: 410-938-3000
?
mi
from
Towson, MD
Click here to add this to my saved trials