MedTrace Logo

Probiotics to Prevent Relapse After Hospitalization for Mania

NCT01731171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-01-07

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic Supplement

Probiotic Supplement 1 tablet by mouth daily

DIETARY_SUPPLEMENT

Inert Compound

Probiotic identical placebo 1 tablet by mouth daily

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Sheppard Pratt Health System

    lead OTHER

Principal Investigators

  • Faith Dickerson, PhD, MPH · Sheppard Pratt Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731171 on ClinicalTrials.gov