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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: MET-2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arthi C Meyyappan, MSc; Phone Number: 647.226.2803; Email: meyyappa@providencecare.ca
• Study Contact Backup: Name: Roumen Milev, MD/PhD; Phone Number: 73002 613.544.4900; Email: milevr@providencecare.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L4X3
      • Recruiting
      • Providence Care Hospital
      • Contact: Cassandra Sgarbossa, BSc; Phone Number: (519) 404-4326; Email: c.sgarbossa@queensu.ca
      • Contact: Roumen Milev, MD, PhD; Phone Number: 73002 (613) 544-4900; Email: milevr@providencecare.ca
    • Toronto, Ontario, Canada, M6J1H4
      • Recruiting
      • CAMH
      • Contact: Ilona Gorbovskaya, MSc; Phone Number: 30231 416 535-8501; Email: ilona.gorbovskaya@camh.ca
      • Contact: Daniel Mueller, MD/PhD; Phone Number: 30851 416 535-8501; Email: daniel.mueller@camh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to provide informed consent.
2. Not pregnant
3. Willing to participate in follow up as part of the study
4. Diagnosis of Major Depressive Disorder (MDD) by the Mini-International Neuropsychiatric Interview (MINI)
5. Current depressive episode with a Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥15.
6. Able to understand and comply with the requirements of the study
7. Able to provide stool, urine, and blood samples.
8. Those who do not choose to use antidepressants for moderate-severe depression.

Exclusion Criteria:

1. History of chronic diarrhea
2. Need for regular use of agents that affect gastro-intestinal (GI) motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
3. Colostomy
4. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
5. History of bariatric surgery.
6. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
7. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
8. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
9. More than three depressive episodes throughout lifetime
10. Having failed an anti-depressant treatment during current depressive episode
11. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
12. History of alcohol or substance dependence in the past 6 months
13. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
14. Use of any type of laxative in the last 2 weeks.
15. Consumption of products fortified in probiotics (may be eligible to participate after a 2-week washout period)
16. High suicidal risk, as measured by MADRS item 10 score more than 3
17. Current psychotic symptoms
18. Bipolar Depression
19. History of epilepsy or uncontrolled seizures
20. 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)
21. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
22. The use of natural health products (NHP); e.g. St. John's Wort, passion flower, etc.) that affect depression
23. History of Electroconvulsive therapy (ECT)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MET-2 20 g; 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; 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.
PLACEBO_COMPARATOR: Placebo; 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; Placebo Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NuBiyota
• Investigators: Principal Investigator: Roumen Milev, MD/PhD, Queens University

Publications and helpful links

General Publications

• Chinna Meyyappan A, Sgarbossa C, Vazquez G, Bond DJ, Muller DJ, Milev R. The Safety and Efficacy of Microbial Ecosystem Therapeutic-2 in People With Major Depression: Protocol for a Phase 2, Double-Blind, Placebo-Controlled Study. JMIR Res Protoc. 2021 Sep 22;10(9):e31439. doi: 10.2196/31439.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (ACTUAL): October 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MET-2 301-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No