DepressionPhase 2/3NCT04805879
The Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
A Phase 2/3 study testing FMT oral Capsules in people with Depression and Treatment Resistant Depression, run by University of Calgary at 1 site in Canada.
Trial summary
The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Treatment Resistant Depression
- What is being tested?
- FMT oral Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2021to 4 Dec 2024
- Phase
- Phase 2/3
- 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
- Between 18-65 years of age:
- Participants should be at least 18 years old and not older than 65 years at the day of screening
- Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
- Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48
- Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
- A MADRS score of ≥ 19 at screening and visit 2
- Additional Inclusion Criteria:
- Participants who will be included in the IBS-D cohort should have a confirmed diagnosis of IBS-D as indicated by the referring gastroenterologist.
Who cannot join
- 1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1 Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis) g) Moderate or severe Substance use disorder for Cannabis use the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophrenia or schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. Use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months 4. Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease) 5. Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cumming School of Medicine, University of Calgary
Calgary, Alberta, T2N 4 Z6
Rachel Research Coordinator, 403-210-8650, fmtmddstudy@ucalgary.ca
Asem Research Manager, 403-210-7282, fmtmddstudy@ucalgary.ca
About this study
Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD).
Read the detailed description
This study is a phase 2/3, double-blinded, randomized controlled trial (RCT) in which 80 adults with TRD being treated with an approved antidepressant medication will be assigned to either FMT capsules or identically appearing placebo capsules. Participant will be followed for f for 14 weeks post FMT. This extended observation period will allow us to see, whether FMT leads to sustainable improvements in depression and changes in intestinal microbiome
- Conditions
- Depression, Treatment Resistant Depression
- Being tested
- FMT oral Capsules, Placebo Capsules
- Keywords
- FMT, Fecal Microbiota Transplantation, Microbiome, gut brain axis, Major depression
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT oral CapsulesBiological
Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool donated by a healthy indvidual that was screened to have no mental health issues or chronic or contagious doseases. Each capsule will contain 0.67 ml of pelleted intestinal microbes. Therefore it is considered that the 20 capsules are equivalent to 100 grams of stool
Placebo CapsulesBiological
Placebo Capsules that will look and weigh the same as the FMT oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| FMT capsules | Active comparator | Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes.
PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that Receives: Biological: FMT oral Capsules |
| Placebo oral Capsules | Placebo comparator | Placebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm. Receives: Biological: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the MADRS total score
To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression
Measured: from baseline (pre-intervention) to the final visit (week 13)
Secondary outcomes (2)
Side effects as reported on the Toronto Side Effect Scale (TSES)
The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES)
Measured: from baseline (pre-intervention) to the final visit (week 13)
GI tolerability of patients with Irritable Bowel Syndrome (IBS)
GI tolerability will be assessed using the IBS Symptom Severity Scale (IBS SSS) and IBS specific Quality of Life (IBS-QoL) questionnaire
Measured: from baseline (pre-intervention) to the final visit (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start4 Mar 2021
- Primary completion4 Mar 2024 (estimated)
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The W. Garfield Westin Foundation
- Responsible party
- Principal investigator, Valerie Taylor, University of Calgary
- Investigators
- Valerie Taylor, MD, PhD, Principal investigator, Cumming School of Medicine, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805879
- Sponsor's protocol ID
- REB#19-0016
- Status last verified
- Nov 2023
- First submitted
- 11 Mar 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04805879
- Acronym / sponsor ID
- REB#19-0016
- Conditions
- Depression, Treatment Resistant Depression
- Keywords
- FMT, Fecal Microbiota Transplantation, Microbiome, gut brain axis, Major depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The W. Garfield Westin Foundation
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 4 Mar 2024 (estimated)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 18 Mar 2021 (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.
The primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral FMT in adults with Treatment Resistant Depression (TRD).
Detailed description
This study is a phase 2/3, double-blinded, randomized controlled trial (RCT) in which 80 adults with TRD being treated with an approved antidepressant medication will be assigned to either FMT capsules or identically appearing placebo capsules. Participant will be followed for f for 14 weeks post FMT. This extended observation period will allow us to see, whether FMT leads to sustainable improvements in depression and changes in intestinal microbiome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT capsules | Active comparator | Biological: FMT oral CapsulesEach dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool and each containing 0.67 ml of pelleted intestinal microbes. PArticipants will recieve a loading dose of 60 capsules over 3 consecutive days followed by a booster dose of 20 caspules 1 month after and a second similar booster dose a month after that |
| Placebo oral Capsules | Placebo comparator | Biological: Placebo CapsulesPlacebo casules are inactive capsules that look and weigh the same as the Active FMT caspules. Participants will follow the same schedule as the Active arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 18-65 years of age:
- Participants should be at least 18 years old and not older than 65 years at the day of screening
- Have a primary diagnosis of MDD according to the M.I.N.I. International Neuropsychiatric Interview (MINI)47
- Medical history suggestive of Treatment Resistant Depression (TRD). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48
- Have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks
Key exclusion criteria (1 listed)
- 1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)1 Criteria for the following conditions according to the M.I.N.I: f) Substance Use Disorder within the last 3 months. *(Criteria should include Alcohol and non-alcohol substances except Cannabis) g) Moderate or severe Substance use disorder for Cannabis use the last 3 months h) Active Anorexia Nervosa or Bulimia nervosa i) Schizophrenia or schizoaffective disorder j) Active suicidality 2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. Use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months 4. Clinically diagnosed chronic gastrointestinal diseases (IBD, Crohn's disease, Ulcerative colitis, Celiac disease) 5. Conditions causing immune suppression 6. Not breastfeeding, pregnant or seeking to get pregnant during the course of this study. Be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner) 7. Reported allergy to Vancomycin or Nitazoxanide
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 |
|---|---|---|
| FMT oral CapsulesEach dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool donated by a healthy indvidual that was screened to have no mental health issues or chronic or contagious doseases. Each capsule will contain 0.67 ml of pelleted intestinal microbes. Therefore it is considered that the 20 capsules are equivalent to 100 grams of stool | Biological | FMT capsules |
| Placebo CapsulesPlacebo Capsules that will look and weigh the same as the FMT oral capsules. | Biological | Placebo oral Capsules |
Primary outcome
Change in the MADRS total score
Time frame: from baseline (pre-intervention) to the final visit (week 13)
To evaluate the effectiveness of adjunct oral FMT as compared to placebo with currently accepted approved therapy for depression
2 secondary outcomes
Side effects as reported on the Toronto Side Effect Scale (TSES)
Time frame: from baseline (pre-intervention) to the final visit (week 13)
GI tolerability of patients with Irritable Bowel Syndrome (IBS)
Time frame: from baseline (pre-intervention) to the final visit (week 13)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Valerie Taylor, MD, PhD principal investigator
Cumming School of Medicine, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FMT oral Capsules in people with Depression and Treatment Resistant Depression, run by University of Calgary 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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asem Bala, BDS, MSc (403-210-7282, asem.bala@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the MADRS total score (time frame: from baseline (pre-intervention) to the final visit (week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.