Depression, Anxiety
Conditions
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.
Interventions
BIOLOGICALMET-2
Subjects will take study medication once daily for the duration of the study
Sponsors
NuBiyota
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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 MDD and/or GAD by MINI 5. Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8. 6. Able to understand and comply with the requirements of the study 7. Able to provide stool and blood samples.
Exclusion criteria
1. History of chronic diarrhea 2. Need for regular use of agents that affect 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. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months 6. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study. 7. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period) 8. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period) 9. History of alcohol or substance dependence in the past 6 months 10. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) 11. Use of any type of laxative in the last 2 weeks. 12. Consumption of products fortified in probiotics 13. High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4) 14. Current psychotic symptoms 15. Bipolar Depression 16. History of epilepsy or uncontrolled seizures 17. 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) 18. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.) 19. The use of natural health products (Natural health products \[NHPs\]; e.g. St. John's Wort, passion flower, etc.) that affect depression 20. History of Electroconvulsive therapy (ECT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Week 10 | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders |
| Generalized Anxiety Disorder - 7 (GAD-7) | Week 10 | The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder. |
Countries
Canada
Outcome results
None listed