Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder

Not Applicable

Recruiting

• Conditions: Bipolar Disorder
• Interventions: Other: Probiotic Group; Other: Placebo Group

• Registration Number: NCT05762887
• Lead Sponsor: University of Sao Paulo

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 84 subjects (42 receiving probiotics and 42 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.

Study Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probiotic Group	In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, subjects will receive food supplementation with a probiotic formulation, twice daily, with food. We will use Pendulum Therapeutics' Glucose Control, probiotic formulation patented in the United States. Probiotic Ingredients: Clostridium butyricum WB-STR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WB-STR-0001, and Bifidobacterium infantis. The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
Placebo Group	Placebo Group	In addition to the usual medication treatment for bipolar disorder, following the main international guidelines for the treatment of bipolar disorder, the subjects will receive food supplementation with a placebo formulation, twice daily, with food We will use Pendulum Therapeutics' placebo formulation that contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil