Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03349528
• Other study ID #: SMRI/SPHS: 2017-01
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 11, 2018
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: Sheppard Pratt Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Recurrence

Intervention

Biological:
• Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily
• Inert Compound
Probiotic identical placebo 1 tablet by mouth daily

Locations

Country	Name	City	State
United States	Sheppart Pratt Health System	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sheppard Pratt Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal Inflammation	Levels of intestinal inflammation as measured by antibodies to casein, gliadin and saccharomyces cerevisiae as well as C-reactive protein (CRP) and cytokines	Baseline, Week 12, Week 24
Primary	Time to Relapse	Time to relapse defined as time until psychiatric rehospitalization during the study period	Weeks 0 - 24 of study participation
Secondary	New Mood Episodes	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)	Weeks 0 - 24 of study participation
Secondary	Brief Psychiatric Rating Scale	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.	Weeks 0 - 24 of study participation
Secondary	Young Mania Rating Scale	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.	Weeks 0 - 24 of study participation
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS)	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.	Weeks 0 - 24 of study participation
Secondary	Hamilton Depression Rating Scale	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.	Weeks 0 - 24 of study participation
Secondary	Columbia-Suicide Severity Rating Scale	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.	Weeks 0 - 24 of study participation