The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

Detailed Description
-----------------
This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

Official Title
-----------------
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Biological: MET-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent. Not pregnant Willing to participate in follow up as part of the study Diagnosis of MDD and/or GAD by MINI Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8. Able to understand and comply with the requirements of the study Able to provide stool and blood samples. Exclusion Criteria: History of chronic diarrhea Need for regular use of agents that affect 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 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) 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 High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4) 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 (Natural health products [NHPs]; e.g. St. John's Wort, passion flower, etc.) that affect depression History of Electroconvulsive therapy (ECT)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an open label study with one arm for subjects diagnosed with major depression disorder and one arm for subjects diagnosed with generalized anxiety disorder
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Major Depression Disorder<br>MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured | Biological: MET-2<br>* Subjects will take study medication once daily for the duration of the study<br>|
| Experimental: Generalized Anxiety Disorder<br>MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured | Biological: MET-2<br>* Subjects will take study medication once daily for the duration of the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders | Week 10 | 
| Generalized Anxiety Disorder - 7 (GAD-7) | The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder. | Week 10 |