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Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Probiotic Supplement
Inert Compound
Sponsored by
Sheppard Pratt Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring bipolar disorder, bipolar depression, depressive episode, probiotic supplement, probiotics, relapse prevention, rehospitalization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheppart Pratt Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic Supplement

Inert Compound

Arm Description

The probiotic supplement will consist of capsules containing approximately 1 billion (1.0 x 10^9) colony forming units of the probiotic organisms, Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis subsp. lactis BB-12® (BB-12®). The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. Participants will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.

The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.

Outcomes

Primary Outcome Measures

Time to Relapse
Time to relapse defined as time until psychiatric rehospitalization during the study period

Secondary Outcome Measures

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)
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.
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.
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.
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.
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.

Full Information

First Posted
November 17, 2017
Last Updated
April 19, 2023
Sponsor
Sheppard Pratt Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03349528
Brief Title
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
bipolar disorder, bipolar depression, depressive episode, probiotic supplement, probiotics, relapse prevention, rehospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Supplement
Arm Type
Experimental
Arm Description
The probiotic supplement will consist of capsules containing approximately 1 billion (1.0 x 10^9) colony forming units of the probiotic organisms, Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis subsp. lactis BB-12® (BB-12®). The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. Participants will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
Arm Title
Inert Compound
Arm Type
Placebo Comparator
Arm Description
The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.
Intervention Type
Biological
Intervention Name(s)
Probiotic Supplement
Other Intervention Name(s)
Probio-Tec® BG-VCap-6.5
Intervention Description
Probiotic supplement 1 tablet by mouth daily
Intervention Type
Biological
Intervention Name(s)
Inert Compound
Intervention Description
Probiotic identical placebo 1 tablet by mouth daily
Primary Outcome Measure Information:
Title
Time to Relapse
Description
Time to relapse defined as time until psychiatric rehospitalization during the study period
Time Frame
Weeks 0 - 24 of study participation
Secondary Outcome Measure Information:
Title
New Mood Episodes
Description
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)
Time Frame
Weeks 0 - 24 of study participation
Title
Brief Psychiatric Rating Scale
Description
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.
Time Frame
Weeks 0 - 24 of study participation
Title
Young Mania Rating Scale
Description
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.
Time Frame
Weeks 0 - 24 of study participation
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Weeks 0 - 24 of study participation
Title
Hamilton Depression Rating Scale
Description
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.
Time Frame
Weeks 0 - 24 of study participation
Title
Columbia-Suicide Severity Rating Scale
Description
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.
Time Frame
Weeks 0 - 24 of study participation
Other Pre-specified Outcome Measures:
Title
Intestinal Inflammation
Description
Levels of intestinal inflammation as measured by antibodies to casein, gliadin and saccharomyces cerevisiae as well as C-reactive protein (CRP) and cytokines
Time Frame
Baseline, Week 12, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Dickerson, PhD, MPH
Organizational Affiliation
Sheppart Pratt Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppart Pratt Health System
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.

Learn more about this trial

Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

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