A Phase 3 interventional study of Probio'Stick and Placebo in Depression and Anxiety, sponsored by Dr. Roumen Milev. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Dr. Roumen Milev · Phase 3, Interventional, and Treatment
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Among 532 studies in Depression with a site in Canada — 107 open to participants now, 124 under way, 7 of them phase 3. Depression · Canada.
Among the 532 studies in Depression with a site in Canada, this one is the 382nd largest by enrollment of the 487 interventional ones that give a count, is one of 35 that started in 2018, is one of 51 in phase 3, and was the 224th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →107 of the 532 studies in Depression with a site in Canada are open now. Recruiting first, the newest first:
Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 18+
Eli Lilly and Company · Sites in Canada, United States, Australia and 12 more countries
Ages 18–75
University of Regina · Sites in Canada
Ages 18+
University of Toronto · Sites in Canada
Ages 18+
Lakshmi N Yatham · Sites in Canada
Ages 19–65
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
532 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 45 · Phase 3 55 · Phase 4 37
First in 1997; this study’s year is marked. 35 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 76 across the 487 interventional studies, 262 across the 45 observational. Of the 345 that completed or were terminated, 45 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
59 of 532 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Dr. Roumen Milev as lead sponsor.
Dr. Roumen Milev has 1 study filed under Depression — fewer than ten, so there is no comparison to draw.
35 of the studies in Depression with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06963021Phase 3Neurocrine BiosciencesNBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) | 2027-07 |
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07313657Bruyère Health Research Institute.Improving Care and Mental Well-Being for Adults With Heart Failure | 2026-11-30 |
| NCT05543720University Health Network, TorontoEvaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study | 2026-12 |
| NCT06745349University of ReginaThe Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties | 2026-12 |
Add all 35 to your calendar (.ics) → With an account.
Among the 532 studies in Depression with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Preclinical and clinical studies have shown that consuming probiotics can improve mood, anxiety, and cognition, as well as alter brain activity in both rodents and healthy humans. Data from our recent open-label, 8-week pilot study provided the first evidence of these effects in depressed patients, with significant improvements observed in overall mood, anhedonia, and sleep quality. To further support this evidence and expand upon the search for biomarkers in depression, data from this pilot study is being used to plan a 16-week, double-blind randomized placebo-controlled trial to assess the effects of probiotics on depression. Participants diagnosed with depression recruited from the greater Kingston area will orally consume a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum (Probio'Stick, Lallemand Health Solutions) or placebo once daily. Participants will undergo clinical assessments measuring mood, anxiety, cognition, and sleep using a battery of validated clinical scales to assess efficacy of the probiotic alleviating depressive symptoms; sleep will also be assessed objectively with an ambulatory polysomnogram. Neuroimaging data will be collected using magnetic resonance imaging and electroencephalography to look at functional, structural, and electrical changes in the brain associated with consumption of the probiotic. Molecular data will be collected from blood, stool, and urine samples to look at levels of cytokines and serotonin, and explore potential genes and proteins that may predict outcomes in depression. An informatics-based approach will be used to integrate clinical, neuroimaging, and molecular data to look for biomarkers that indicate disease state and predict antidepressant-like response to the probiotic. Results: We expect results to replicate and expand on our pilot data, demonstrating that probiotics are effective in alleviating symptoms of depression, and to find biomarkers that will predict these outcomes. The findings from this study will contribute robust scientific data that is currently lacking in this emerging field.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Probio'Stick
Drug: Placebo
Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum
Identically formulated and packaged inactive substance
Mood
Montgomery-Asberg Depression Rating Scale
Time frame: 16 weeks
Anxiety
Generalized Anxiety Disorder 7-item Scale
Time frame: 16 weeks
Anhedonia
Snaith Hamilton Pleasure Scale
Time frame: 16 weeks
Cognition
CNS Vital Signs
Time frame: 16 weeks
Cytokines
Blood plasma
Time frame: 16 weeks
Serotonin
Blood Plasma
Time frame: 16 weeks
Microbiome
Stool
Time frame: 16 weeks
Brain structure/function
fMRI
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Nov 2020, 30 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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