Bipolar Disorder
Conditions
Brief summary
Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 124 subjects (62 receiving probiotics and 62 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.
Detailed description
It will test, in a proof-of-concept study, the antidepressant efficacy of adjunctive administration of probiotics in bipolar depression and evaluate potential inflammatory and metabolic markers associated with response to treatment. With this objective, 84 individuals with bipolar disorder type I or type II presenting subsyndromal depressive symptoms or a major depressive episode will be recruited. The study design lasts 12 weeks and is expected to last two years.
Interventions
OTHERProbiotic Group
The 124 participants will participate in a randomized, double-blind, placebo-controlled trial in two arms. The probiotic group will consist of 62 patients. These patients will be recruited from the USP Bipolar Disorder Program. This program has an outpatient clinic that offers free medical care to a population of different ethnic groups, with the majority of subjects coming from the middle and lower social classes.
OTHERPlacebo Group
The 124 participants will participate in a randomized, double-blind, placebo-controlled trial in two arms. The placebo group will consist of 62 patients. These patients will be recruited from the USP Bipolar Disorder Program. This program has an outpatient clinic that offers free medical care to a population of different ethnic groups, with the majority of subjects coming from the middle and lower social classes.
Sponsors
University of Sao Paulo
Baszucki Brain Research Fund
Milken Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All blind clinical assessments will be done by Psychiatrists, members of the University of São Paulo (USP) Bipolar Research Program managed by Michelle Flores. In this study, the intervention will be double-blind: All participants will receive the exact same pill, whether placebo or intervention, with equal packaging-manufacturing.
Intervention model description
A Randomized, Double-Blind, Placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI) * Score on the Young Mania Rating Scale (YMRS) \< 8 * Score on the Montgomery-Asberg Depression Rating Scale (MADRS) \> 8 * Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks
Exclusion criteria
* Pregnant or lactating women * Substance or alcohol dependence * Patients on prolonged antibiotic therapy, immunosuppressive therapies * A recent introduction of antidepressants in the last 15 days * Use of another probiotic, either in the form of food, sachets, capsules and others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome | 12 weeks | The Montgomery-Asberg Depression Rating Scale (MADRS) will be used in order to evaluate the reduction of depressive symptoms. Response to treatment at week-12 will be defined as ≥ 50% reduction in total MADRS total score from baseline. Remission will be defined as MADRS total score ≤ 12. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORBeny lafer, PhD
University of Sao Paulo
Outcome results
None listed