Probiotics to Prevent Relapse After Hospitalization for Mania
A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
1 other identifier
interventional
66
1 country
1
Brief Summary
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
January 7, 2019
CompletedJanuary 7, 2019
January 1, 2019
4.1 years
November 15, 2012
May 3, 2018
January 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Rehospitalization
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Weeks 0 - 24 of study participation
Secondary Outcomes (3)
Number of Participants Rehospitalized
Weeks 0 - 24 of study participation
Total Number of Rehospitalizations
Weeks 0 - 24 of study participation
Mean Days Rehospitalized
Weeks 0 - 24 of study participation
Study Arms (2)
Probiotic Supplement
EXPERIMENTALThe probiotic supplement compound will consist of capsules containing approximately 10\^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
Inert Compound
PLACEBO COMPARATORThe 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.
Interventions
Probiotic Supplement 1 tablet by mouth daily
Eligibility Criteria
You may qualify if:
- Age 18-65
- Capacity for written informed consent
- Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania
- Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (single manic episode, most recent episode manic, or most recent episode mixed) OR Schizoaffective Disorder, Bipolar type (manic or mixed state)
- Proficient in the English language
- Available to come to Sheppard Pratt Towson for follow-up visits
- Participated previously in one of our screening studies
You may not qualify if:
- Diagnosis of mental retardation
- Symptoms of mania secondary to a general medical condition
- Any clinically significant or unstable medical disorder as determined by the investigators including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition
- History of IV drug use
- Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last 3 months, or has a positive drug toxicity screen
- Participated in any investigational drug trial in the past 30 days
- Pregnant or planning to become pregnant during the study period
- Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics)
- Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care). Of note, we are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as we intend to look at these levels as a predictor of response.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheppard Pratt Health Systemlead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
Sheppard Pratt Health System
Baltimore, Maryland, 21285, United States
Related Publications (1)
Dickerson F, Adamos M, Katsafanas E, Khushalani S, Origoni A, Savage C, Schweinfurth L, Stallings C, Sweeney K, Goga J, Yolken RH. Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: A randomized controlled trial. Bipolar Disord. 2018 Nov;20(7):614-621. doi: 10.1111/bdi.12652. Epub 2018 Apr 25.
PMID: 29693757DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Faith Dickerson
- Organization
- Sheppard Pratt Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Faith Dickerson, PhD, MPH
Sheppard Pratt Health System
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Stanley Research Program
Study Record Dates
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 7, 2019
Results First Posted
January 7, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share