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

NCT04052451 | Completed Phase 1

• 1 other identifier: MET-2-301
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders

  Week 10

• Generalized Anxiety Disorder - 7 (GAD-7)

  The GAD-7 is a seven domain, self-reported questionnaire for screening and assessing severity of generalized anxiety disorder.

  Week 10

Study Arms (2)

Major Depression Disorder

EXPERIMENTAL

MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured

Biological: MET-2

Generalized Anxiety Disorder

EXPERIMENTAL

MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured

Biological: MET-2

Interventions

MET-2 BIOLOGICAL

Subjects will take study medication once daily for the duration of the study

Generalized Anxiety Disorder; Major Depression Disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent.
• Not pregnant
• Willing to participate in follow up as part of the study
• Diagnosis of MDD and/or GAD by MINI
• Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8.
• Able to understand and comply with the requirements of the study
• Able to provide stool and blood samples.

You may not qualify if:

• History of chronic diarrhea
• Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
• Colostomy
• Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
• Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
• Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
• Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
• Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
• History of alcohol or substance dependence in the past 6 months
• Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
• Use of any type of laxative in the last 2 weeks.
• Consumption of products fortified in probiotics
• High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)
• Current psychotic symptoms
• Bipolar Depression

Sponsors & Collaborators

• NuBiyota: lead

Study Sites (1)

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location

Related Publications (1)

• Chinna Meyyappan A, Forth E, Milev R. Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study. Interact J Med Res. 2022 Jan 21;11(1):e32234. doi: 10.2196/32234.

  PMID: 35060914 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: May 16, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)