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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602715
• Other study ID #: MET-2 301-2
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: June 2021

Study information

• Verified date: April 2021
• Source: NuBiyota
• Contact: Arthi C Meyyappan, MSc
• Phone: 647.226.2803
• Email: meyyappa[@]providencecare.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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
Placebo Control

Locations

Country	Name	City	State
Canada	Providence Care Hospital	Kingston	Ontario
Canada	CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
NuBiyota

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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