Depression, AnxietyPhase 1NCT04052451
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
A Phase 1 study testing MET-2 in people with Depression, Anxiety, run by NuBiyota at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- MET-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2019to 1 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- History of epilepsy or uncontrolled seizures
- 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)
- Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
- The use of natural health products (Natural health products [NHPs]; e.g. St. John's Wort, passion flower, etc.) that affect depression
- History of Electroconvulsive therapy (ECT)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- MET-2
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET-2Biological
Subjects will take study medication once daily for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Major Depression Disorder | Experimental | MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured Receives: 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 Receives: Biological: MET-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start16 May 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuBiyota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052451
- Sponsor's protocol ID
- MET-2-301
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
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.
PubMed 35060914
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT04052451
- Acronym / sponsor ID
- MET-2-301
- Conditions
- Depression, Anxiety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NuBiyotaUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Major Depression Disorder | Experimental | Biological: MET-2MET-2 will be given to subjects with major depression disorder and its effect on mood will be measured |
| Generalized Anxiety Disorder | Experimental | Biological: MET-2MET-2 will be given to subjects with generalized anxiety disorder and its effect on mood will be measured |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MET-2Subjects will take study medication once daily for the duration of the study | Biological | Generalized Anxiety Disorder, Major Depression Disorder |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 35060914Chinna 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MET-2 in people with Depression, Anxiety, run by NuBiyota at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.