Probiotics to Prevent Relapse After Hospitalization for Mania
This study is currently recruiting participants.
Verified February 2013 by Sheppard Pratt Health System
Sponsor:
Sheppard Pratt Health System
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System
ClinicalTrials.gov Identifier:
NCT01731171
First received: November 15, 2012
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Disorder Schizoaffective Disorder |
Dietary Supplement: Probiotic Supplement Dietary Supplement: Inert Compound |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Mania |
Resource links provided by NLM:
Further study details as provided by Sheppard Pratt Health System:
Primary Outcome Measures:
- Time to relapse [ Time Frame: Weeks 1 - 24 of study participation ] [ Designated as safety issue: No ]Time to relapse is defined as time until re-hospitalization during the study period after a minimum of a 2 week interval after discharge from a previous hospital stay.
Secondary Outcome Measures:
- New mood episode [ Time Frame: Weeks 1 - 24 of study participation ] [ Designated as safety issue: No ]New mood episodes are defined by DSM-IV criteria for a manic, mixed, or depressive episode.
| Estimated Enrollment: | 66 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotic Supplement
The 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.
|
Dietary Supplement: Probiotic Supplement
Probiotic Supplement 1 tablet PO QD
Other Name: Probio-Tec
|
|
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.
|
Dietary Supplement: Inert Compound
Probiotic identical placebo 1 tablet PO QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731171
Contacts
| Contact: Cassie Stallings | 410-938-3000 |
Locations
| United States, Maryland | |
| Sheppard Pratt Health System | Recruiting |
| Batlimore, Maryland, United States, 21285 | |
Sponsors and Collaborators
Sheppard Pratt Health System
Stanley Medical Research Institute
More Information
No publications provided
| Responsible Party: | Faith Dickerson, PhD, MPH, Head, Stanley Research Program, Sheppard Pratt Health System |
| ClinicalTrials.gov Identifier: | NCT01731171 History of Changes |
| Other Study ID Numbers: | SMRI/SPHS: 2012/1 |
| Study First Received: | November 15, 2012 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by Sheppard Pratt Health System:
|
mania manic episode mixed episode bipolar disorder schizoaffective disorder |
probiotics probiotic supplement relapse prevention new mood episode re-hospitalization |
Additional relevant MeSH terms:
|
Bipolar Disorder Psychotic Disorders Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 18, 2013