The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression

Study Overview
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Brief Summary
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To measure the effects of Microbial Ecosystem Therapeutics (MET)-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety

Detailed Description
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An eight week, randomized, placebo controlled trial to assess subjective changes in mood and anxiety symptoms from baseline to after MET-2 treatment in participants with depression, using MADRS, Hamilton Anxiety Rating Scale (HAM-A), and other mood/anxiety scales and to demonstrate a significantly higher proportion of responders in patient who were randomized to receive the active study drug compared to patients who were randomized to receive placebo.

Official Title
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The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression

Conditions
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Anxiety, Major Depressive Disorder

Intervention / Treatment
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* Drug: MET-2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide informed consent. Not pregnant Willing to participate in follow up as part of the study Diagnosis of Major Depressive Disorder (MDD) by the Mini-International Neuropsychiatric Interview (MINI) Current depressive episode with a Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥15. Able to understand and comply with the requirements of the study Able to provide stool, urine, and blood samples. Those who do not choose to use antidepressants for moderate-severe depression. Exclusion Criteria: History of chronic diarrhea Need for regular use of agents that affect gastro-intestinal (GI) motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide) Colostomy Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment History of bariatric surgery. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months Any condition for which, in the opinion of the investigator, the participant should be excluded from the study. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period) More than three depressive episodes throughout lifetime Having failed an anti-depressant treatment during current depressive episode Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period) History of alcohol or substance dependence in the past 6 months Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) Use of any type of laxative in the last 2 weeks. Consumption of products fortified in probiotics (may be eligible to participate after a 2-week washout period) High suicidal risk, as measured by MADRS item 10 score more than 3 Current psychotic symptoms Bipolar Depression History of epilepsy or uncontrolled seizures Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome [AIDS], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants) Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.) The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression History of Electroconvulsive therapy (ECT)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arm, randomized, placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MET-2 20 g<br>Loading dose of MET-2 is administered for the first two days, followed by a regular, daily dose for the duration of the study (6 weeks total).The loading dose will consist of 5 g of MET-2 in the form of ten capsules orally on day one and on day two. The regular daily dose will consist of 1.5 g MET-2 in the form of three MET-2 capsules taken once daily, excluding days where they take the booster (same as loading dose). | Drug: MET-2<br>* Subjects will take capsules containing MET-2 daily during the trial. There will be a loading dose at the start of dosing, and a daily dose. There will be a booster dose given at week 2 and a second booster dose taken at week 4 for those subjects who have not improved by that time.<br>|
| Placebo Comparator: Placebo<br>Loading dose of placebo is administered for the first two days, followed by a regular, daily dose of placebo for the duration of the study (6 weeks total).The loading dose will consist of ten capsules of placebo (which match the MET-2 capsules in appearance and weight) taken orally on day one and on day two. The regular daily dose will consist of three placebo capsules taken once daily, excluding days where they take the booster (same as loading dose). | Drug: Placebo<br>* Placebo Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Major Depression Symptoms | To assess subjective changes in mood from baseline to after MET-2 treatment using the Montgomery-Asberg Depression Rating Scale (10 domains given a rating from 0 to 6) | Baseline vs. Week 6 | 
| Change in Anxiety Symptoms | To assess subjective changes in anxiety symptoms from baseline to after MET-2 treatment using the Hamilton Anxiety Rating Scale (14 domains given a rating on a 5 point scale) | Baseline vs. Week 6 |