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The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People with Major Depression (METDA)
Microbial Ecosystem Therapeutics (MET-2) is a new treatment approach for repopulating the gut with healthy microbiota that has been developed as an alternative to fecal transplantation. This is a biological compound comprised of live microbes that normally reside in the human gut of a healthy individual. This randomized control trial with placebo will aim to measure the effects of MET-2 on symptoms of depression and anxiety using baseline and post-treatment scores to measure changes in symptom presentation. This will be accomplished by assessing subjective changes in mood and anxiety symptoms biweekly for eight weeks, from baseline, to after completion of MET-2 treatment in participants with depression, using the MADRS, HAM-A, and other mood and anxiety scales. Changes in metabolic levels and functioning before, during, and after treatment will also be assessed, along with potential correlation between early life stress (history of emotional/physical/sexual abuse, etc.), changes in Major Depressive Disorder, and response to treatment.
Learn more about the gut microbiome and our research.
CAN-BIND-2 Validation Study
The objective of this study is to integrate detailed clinical, neuroimaging, EEG, and molecular data to predict treatment outcome for patients experiencing a Major Depressive Episode (MDE), and receiving pharmacotherapy reflective of standard practice. Stool samples will also be collected to integrate microbiota measures into data analyses, as well as blood samples for genomic profiling.
The CAN-BIND Validation cohort will consist of participants who are diagnosed with clinical depression, and are currently experiencing a depressive episode. Participation in this study lasts for 16 weeks from the time participants begin taking their medication.
Participants will receive standard, open-label treatment. For the first eight weeks, patients will receive evidence-based, antidepressant treatment with Cipralex® (escitalopram) (10-20mg). After eight weeks, patients who responded to the medication will continue on their effective dose and will be followed for a further 8 weeks. Those who did not respond to treatment will receive open-label, add-on medication with Rexulti® (brexpiprazole) (0.5-2mg). Clinical, neurophysiology, molecular biomarker, and neuroimaging evaluations will be conducted regularly (approximately every 2-4 weeks) for the duration of treatment.
To learn more about CAN-BIND, visit our website.