Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in the depressive symptoms severity
- Last Updated
- 5 years ago
Overview
Brief Summary
The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.
Detailed Description
Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10\^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.
Investigators
Antonio L Teixeira Jr
Principal Investigator
Federal University of Minas Gerais
Eligibility Criteria
Inclusion Criteria
- •Aged between 18 and 65 years old;
- •Diagnosis of major depression
- •Agree to sign the informed consent.
Exclusion Criteria
- •Treatment with anti-inflammatory drugs or antibiotics of any pharmacological classes in the month before treatment enrollment;
- •Use of dietary supplementation (herbal supplements, other pro- or prebiotics).
Outcomes
Primary Outcomes
Change in the depressive symptoms severity
Time Frame: 8 weeks
Depression symptoms severity will be assessed through the Montgomery-Asberg Depression Rating Scale (MADRS) (Minimum: 0 to 6 - normal/symptom absent/ Maximum: \>34 - severe depression). Higher scores mean a worse outcome.
Secondary Outcomes
- Change in perception of stress(8 weeks)
- Change in microbiota composition(8 weeks)
- Changes in the serum levels of biomarkers(8 weeks)