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The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052451
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
NuBiyota

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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Biological: MET-2 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Major Depression Disorder
MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured
Biological: MET-2
Subjects will take study medication once daily for the duration of the study

Experimental: Generalized Anxiety Disorder
MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured
Biological: MET-2
Subjects will take study medication once daily for the duration of the study




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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

  2. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Week 10 ]
    The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052451


Locations
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Canada, Ontario
Providence Care Hospital
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
NuBiyota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NuBiyota
ClinicalTrials.gov Identifier: NCT04052451    
Other Study ID Numbers: MET-2-301
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders