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OpenTrials
Completed

NCT Number: NCT01731171

Probiotics to Prevent Relapse After Hospitalization for Mania

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic supplement

Dietary Supplement

Probiotic Supplement 1 tablet by mouth daily

Other names: Probio-Tec

Inert Compound

Dietary Supplement

Probiotic identical placebo 1 tablet by mouth daily

Primary outcomes

  1. Time to First Rehospitalization

    Time frame: Weeks 0 - 24 of study participation

    The primary outcome was the time to first psychiatric inpatient rehospitalization.

Secondary outcomes

  1. Number of Participants Rehospitalized

    Time frame: Weeks 0 - 24 of study participation

    This is a count of the participants who had at least one rehospitalization during the study period.

  2. Total Number of Rehospitalizations

    Time frame: Weeks 0 - 24 of study participation

    This is a count of the number of rehospitalizations in each group during the study period.

  3. Mean Days Rehospitalized

    Time frame: Weeks 0 - 24 of study participation

    This is the mean number of days rehospitalized for participants in each group during the study period.

Sponsors and collaborators

Lead sponsor

Sheppard Pratt Health System

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 21, 2012
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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