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Trial record 2 of 39 for:    Recruiting Studies | Interventional Studies | Bipolar Depression

Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression

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ClinicalTrials.gov Identifier: NCT03349528
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Faith Dickerson, Sheppard Pratt Health System

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE December 11, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Time to Relapse [ Time Frame: Weeks 0 - 24 of study participation ]
Time to relapse defined as time until psychiatric rehospitalization during the study period
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03349528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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)
  • Brief Psychiatric Rating Scale [ Time Frame: Weeks 0 - 24 of study participation ]
    Severity of psychiatric symptoms determined by Brief Psychiatric Rating Scale (BPRS)
  • Young Mania Rating Scale [ Time Frame: Weeks 0 - 24 of study participation ]
    Severity of mania-related symptoms determined by Young Mania Rating Scale (YMRS)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Weeks 0 - 24 of study participation ]
    Severity of depression-related symptoms determined by Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Hamilton Depression Rating Scale [ Time Frame: Weeks 0 - 24 of study participation ]
    Severity of depression-related symptoms determined by Hamilton Depression Rating Scale (HAM-D)
  • Columbia-Suicide Severity Rating Scale [ Time Frame: Weeks 0 - 24 of study participation ]
    Occurrence of suicide attempts and ideation during the treatment period determined by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Current Other Pre-specified Outcome Measures
 (submitted: May 25, 2018)
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
Original Other Pre-specified Outcome Measures
 (submitted: November 17, 2017)
Intestinal Inflammation [ Time Frame: Baseline, Week 12, Week 24 ]
Levels of immune markers related to intestinal inflammation
 
Descriptive Information
Brief Title  ICMJE Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
Official Title  ICMJE A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Bipolar Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE
  • Biological: Probiotic Supplement
    Probiotic supplement 1 tablet by mouth daily
    Other Name: Probio-Tec® BG-VCap-6.5
  • Biological: Inert Compound
    Probiotic identical placebo 1 tablet by mouth daily
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Probiotic Supplement
  • 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.
    Intervention: Biological: Inert Compound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cassie Stallings, RNC, MA 410-938-3000 cstallings@sheppardpratt.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03349528
Other Study ID Numbers  ICMJE SMRI/SPHS: 2017-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Faith Dickerson, Sheppard Pratt Health System
Study Sponsor  ICMJE Sheppard Pratt Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Faith Dickerson, PhD, MPH Sheppart Pratt Health System
PRS Account Sheppard Pratt Health System
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP