NCT04602715

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NuBiyota · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Anxiety

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo Control

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-10-26
• Last updated: 2021-05-11

Locations

2 sites across 1 country: Canada