Probiotics to Prevent Relapse After Hospitalization for Mania

This study is enrolling participants by invitation only.
Sponsor:
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: August 5, 2014
Last verified: August 2014
  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 Study Completion Date: November 2015
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 by mouth daily
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 by mouth daily

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731171

Locations
United States, Maryland
Sheppard Pratt Health System
Batlimore, Maryland, United States, 21285
Sponsors and Collaborators
Sheppard Pratt Health System
Stanley Medical Research Institute
Investigators
Principal Investigator: Faith Dickerson, PhD, MPH Sheppard Pratt Health System
  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: August 5, 2014
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
Disease
Psychotic Disorders
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014