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

• Sponsor: NuBiyota (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04602715
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 2
• Patients Per Site: 30
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Anxiety	Drug: MET-2; Drug: Placebo	Phase 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two arm, randomized, placebo controlledtwo arm, randomized, placebo controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Hospital pharmacies will be provided with the randomization code and will dispense the appropriate medication to subjects. A fire-wall exists between the pharmacies and the investigational staff.
• Primary Purpose: Treatment
• Official Title: The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Major Depression Symptoms [Baseline vs. Week 6]

   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)

2. Change in Anxiety Symptoms [Baseline vs. Week 6]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Care Hospital	Kingston	Ontario	Canada	K7L4X3
2	CAMH	Toronto	Ontario	Canada	M6J1H4

Sponsors and Collaborators

• NuBiyota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NuBiyota
• ClinicalTrials.gov Identifier: NCT04602715
• Other Study ID Numbers: MET-2 301-2
• First Posted: Oct 26, 2020
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of May 11, 2021