Probiotics to Prevent Relapse After Hospitalization for Mania

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731171
• Other study ID #: SMRI/SPHS: 2012/1
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Sheppard Pratt Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Psychotic Disorders
• Recurrence
• Schizoaffective Disorder

Intervention

Dietary Supplement:
• Probiotic Supplement
Probiotic Supplement 1 tablet by mouth daily
• Inert Compound
Probiotic identical placebo 1 tablet by mouth daily

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sheppard Pratt Health System	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Rehospitalization	The primary outcome was the time to first psychiatric inpatient rehospitalization.	Weeks 0 - 24 of study participation
Secondary	Number of Participants Rehospitalized	This is a count of the participants who had at least one rehospitalization during the study period.	Weeks 0 - 24 of study participation
Secondary	Total Number of Rehospitalizations	This is a count of the number of rehospitalizations in each group during the study period.	Weeks 0 - 24 of study participation
Secondary	Mean Days Rehospitalized	This is the mean number of days rehospitalized for participants in each group during the study period.	Weeks 0 - 24 of study participation