Clinical trial NCT01731171: Probiotics to Prevent Relapse After Hospitalization for Mania
Official title: A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Schizoaffective Disorder
Keywords: mania
manic episode
mixed episode
bipolar disorder
schizoaffective disorder
probiotics
probiotic supplement
relapse prevention
new mood episode
re-hospitalization
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2012-11-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Time to First Rehospitalization
timeFrame: Weeks 0 - 24 of study participation
Secondary outcomes:
measure: Number of Participants Rehospitalized
timeFrame: Weeks 0 - 24 of study participation
measure: Total Number of Rehospitalizations
timeFrame: Weeks 0 - 24 of study participation
measure: Mean Days Rehospitalized
timeFrame: Weeks 0 - 24 of study participation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Faith Dickerson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dickerson F, Adamos M, Katsafanas E, Khushalani S, Origoni A, Savage C, Schweinfurth L, Stallings C, Sweeney K, Goga J, Yolken RH. Adjunctive probiotic microorganisms to prevent rehospitalization in patients with acute mania: A randomized controlled trial. Bipolar Disord. 2018 Nov;20(7):614-621. doi: 10.1111/bdi.12652. Epub 2018 Apr 25.