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Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349528
Recruitment Status : Enrolling by invitation
First Posted : November 21, 2017
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Faith Dickerson, Sheppard Pratt Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Biological: Probiotic Supplement Biological: Inert Compound Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotic Supplement
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.
 Biological: Probiotic Supplement
Probiotic supplement 1 tablet by mouth daily
Other Name: Probio-Tec® BG-VCap-6.5
Placebo Comparator: Inert Compound
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.
 Biological: Inert Compound
Probiotic identical placebo 1 tablet by mouth daily


Outcome Measures
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Primary Outcome Measures :
  1. Time to Relapse [ Time Frame: Weeks 0 - 24 of study participation ]
    Time to relapse defined as time until psychiatric rehospitalization during the study period


Secondary Outcome Measures :
  1. New Mood Episodes [ Time Frame: 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)

  2. Brief Psychiatric Rating Scale [ Time Frame: 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.

  3. Young Mania Rating Scale [ Time Frame: 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.

  4. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 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.

  5. Hamilton Depression Rating Scale [ Time Frame: 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.

  6. Columbia-Suicide Severity Rating Scale [ Time Frame: 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.


Other Outcome Measures:
  1. Intestinal Inflammation [ Time Frame: 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


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349528


Locations
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United States, Maryland
Sheppart Pratt Health System
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
Investigators
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Principal Investigator: Faith Dickerson, PhD, MPH Sheppart Pratt Health System
More Information
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Responsible Party: Faith Dickerson, Principal Investigator, Stanley Research Program, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT03349528    
Other Study ID Numbers: SMRI/SPHS: 2017-01
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Faith Dickerson, Sheppard Pratt Health System:
bipolar disorder
bipolar depression
depressive episode
probiotic supplement
 probiotics
relapse prevention
rehospitalization
Additional relevant MeSH terms:
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Recurrence
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Bipolar and Related Disorders