Bipolar Disorder, Schizoaffective Disorder
Conditions
Keywords
mania, manic episode, mixed episode, bipolar disorder, schizoaffective disorder, probiotics, probiotic supplement, relapse prevention, new mood episode, re-hospitalization
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.
Interventions
DIETARY_SUPPLEMENTProbiotic Supplement
Probiotic Supplement 1 tablet by mouth daily
DIETARY_SUPPLEMENTInert Compound
Probiotic identical placebo 1 tablet by mouth daily
Sponsors
Stanley Medical Research Institute
Sheppard Pratt Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rehospitalization | Weeks 0 - 24 of study participation | The primary outcome was the time to first psychiatric inpatient rehospitalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Rehospitalized | Weeks 0 - 24 of study participation | This is a count of the participants who had at least one rehospitalization during the study period. |
| Total Number of Rehospitalizations | Weeks 0 - 24 of study participation | This is a count of the number of rehospitalizations in each group during the study period. |
| Mean Days Rehospitalized | Weeks 0 - 24 of study participation | This is the mean number of days rehospitalized for participants in each group during the study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily | 33 |
| 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.
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Moved out of Area | 0 | 2 |
| Overall Study | Terminated for Lack of Adherence | 0 | 1 |
| Overall Study | Terminated for Safety Reasons | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Probiotic Supplement | Inert Compound | Total |
|---|---|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 11.7 | 33.3 years STANDARD_DEVIATION 13.3 | 35.58 years STANDARD_DEVIATION 12.66 |
| Race/Ethnicity, Customized Race African American | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Caucasian | 29 Participants | 21 Participants | 50 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 24 Participants | 18 Participants | 42 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 31 / 33 | 29 / 33 |
| serious Total, serious adverse events | 8 / 33 | 17 / 33 |
Outcome results
Primary
Time to First Rehospitalization
The primary outcome was the time to first psychiatric inpatient rehospitalization.
Time frame: Weeks 0 - 24 of study participation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Probiotic Supplement | Time to First Rehospitalization | 168 Days to first readmission |
| Inert Compound | Time to First Rehospitalization | 139 Days to first readmission |
p-value: =0.029Regression, Logistic
Secondary
Mean Days Rehospitalized
This is the mean number of days rehospitalized for participants in each group during the study period.
Time frame: Weeks 0 - 24 of study participation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Probiotic Supplement | Mean Days Rehospitalized | 2.8 Days | Standard Deviation 6.3 |
| Inert Compound | Mean Days Rehospitalized | 8.3 Days | Standard Deviation 12.4 |
p-value: =0.017Kruskal-Wallis
Secondary
Number of Participants Rehospitalized
This is a count of the participants who had at least one rehospitalization during the study period.
Time frame: Weeks 0 - 24 of study participation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Probiotic Supplement | Number of Participants Rehospitalized | 8 Participants |
| Inert Compound | Number of Participants Rehospitalized | 17 Participants |
p-value: =0.022Chi-squared
Secondary
Total Number of Rehospitalizations
This is a count of the number of rehospitalizations in each group during the study period.
Time frame: Weeks 0 - 24 of study participation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Probiotic Supplement | Total Number of Rehospitalizations | 8 rehospitalizations |
| Inert Compound | Total Number of Rehospitalizations | 24 rehospitalizations |
p-value: =0.009Regression, Linear