Anxiety, Major Depressive Disorder
Conditions
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
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.
Interventions
DRUGMET-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.
DRUGPlacebo
Placebo Control
Sponsors
NuBiyota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
two arm, randomized, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Canada
Contacts
Primary ContactArthi C Meyyappan, MSc
Backup ContactRoumen Milev, MD/PhD
Outcome results
None listed