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

Bipolar Disorder Clinical Trial

Official title:

Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder and Possible Mediating Effects of Systemic and Intestinal Inflammatory Markers in the Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762887
• Other study ID #: U1111-1280-7625
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: University of Sao Paulo
• Contact: Adiel Rios, MD
• Phone: 5511945084970
• Email: adiel.rios[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Probiotic Group
The 84 participants will participate in a randomized, double-blind, placebo-controlled trial in two arms. The probiotic group will consist of 42 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.
• Placebo Group
The 84 participants will participate in a randomized, double-blind, placebo-controlled trial in two arms. The placebo group will consist of 42 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Baszucki Brain Research Fund, Milken Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Dinan TG, Cryan JF. The Microbiome-Gut-Brain Axis in Health and Disease. Gastroenterol Clin North Am. 2017 Mar;46(1):77-89. doi: 10.1016/j.gtc.2016.09.007. Epub 2017 Jan 4. — View Citation

Ho P, Ross DA. More Than a Gut Feeling: The Implications of the Gut Microbiota in Psychiatry. Biol Psychiatry. 2017 Mar 1;81(5):e35-e37. doi: 10.1016/j.biopsych.2016.12.018. No abstract available. — View Citation

Huang R, Wang K, Hu J. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Aug 6;8(8):483. doi: 10.3390/nu8080483. — View Citation

Miyaoka T, Kanayama M, Wake R, Hashioka S, Hayashida M, Nagahama M, Okazaki S, Yamashita S, Miura S, Miki H, Matsuda H, Koike M, Izuhara M, Araki T, Tsuchie K, Azis IA, Arauchi R, Abdullah RA, Oh-Nishi A, Horiguchi J. Clostridium butyricum MIYAIRI 588 as — View Citation

Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 dia — View Citation

Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome	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.	12 weeks