Parkinson DiseasePhase 2ProDNCT05568498
Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
A Phase 2 study testing Probiotic in people with Parkinson Disease and Depression, run by University of British Columbia at 1 site in Canada.
Trial summary
This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Depression, PARKINSON DISEASE (Disorder)
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- Between the ages of 40-80 years
- Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
- Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
- Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices, vasectomy/tubal litigation, barrier methods and double barrier method) and must have negative pregnancy test results at screening and baseline
- Willingness to maintain current physical activity levels during study period
- English proficiency
Who cannot join
- Atypical Parkinsonism
- Active suicidality
- Active psychosis
- Cognitive score (MoCA) of < 21 in the "ON" state
- Severe depression (BDI-II score > 28 in the "ON" state)
- Probiotic, Saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)
Show all 22Show fewer
- The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)
- Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks
- Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
- Change in Parkinson's medication within the last 2 weeks
- Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumour, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
- A significant immune-compromised condition due to either a health condition or use of an immune suppressant (e.g., AIDS, lymphoma, chemotherapy treatment, patients undergoing long-term systemic corticosteroid or immunosuppressant treatment)
- A known bleeding disorder
- Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
- Allergy to corn starch or corn
- Concurrent treatment for Parkinson's disease with Duodopa
- Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks
- New onset of significant psychiatric symptoms following DBS procedure that are considered likely related
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
- Drug and/or substance abuse
- The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. This includes any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a significant language barrier or cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6T2B5
Annie Kuan, 604-827-0576, annie.kuan@ubc.ca
Silke Appel-Cresswell, MD, FRCPC
About this study
This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.
Read the detailed description
Parkinson's disease (PD) is a complex condition that carries a high burden of neuropsychiatric comorbidities. About a third of individuals living with PD have one or more depressive disorders, resulting in lower quality of life, greater care dependency, and increased caregiver burden. Gastrointestinal dysfunction is also very common in PD. Constipation is experienced by the vast majority of patients and often manifests years before onset of motor symptoms. Symptoms suggestive of irritable bowel syndrome (IBS) are also commonly found in PD. Increased intestinal permeability has been demonstrated in PD; impaired intestinal barrier function can lead to chronic systemic low-grade inflammation, which has been strongly associated with mood disorders. Several lines of evidence suggest a link between the gut microbiome and PD.
The microbiome has been linked to depression both in human and animal studies. Several studies have found beneficial effects of probiotics on mood disorders in non-PD populations, including stress and depressive behaviour in animal models, and sad mood reactivity and major depressive disorder (MDD) in humans.
In summary, given the high rate of depression in PD, the growing evidence that probiotics may improve depression and mood disorders in non-PD populations, and the strong links between the gut microbiome and PD, we will carry out a randomized, triple-blinded, placebo-controlled study into the use of a multi-strain probiotic to improve depression and PD.
Recruitment: Approximately 60 participants will be randomized to either the probiotic intervention arm or the placebo intervention arm. Participants will mainly be recruited from the Pacific Parkinson's Research Centre (PPRC) Movement Disorder Clinic at the University of British Columbia (UBC) in Vancouver.
Participants will receive a detailed description of the study and will need to provide informed consent for participation in the study. Participants will be screened for inclusion and exclusion criteria, which include completing screening questionnaires and reviewing medications/medical history.
Assessments: Clinical assessments of motor function, cognition and neuropsychiatric symptoms will be administered before the 12-week intervention phase, as well as following the 12-week intervention. Phone check-ins at weeks 4 and 8 during the intervention will be done to record adverse events and medication/lifestyle changes. Remote questionnaires will be sent to participants at every time point (visit 1, week 4 check-in, week 8 check-in, final visit). Blood samples and stool samples will be collected before and after the intervention. Blood (18mL) will be collected at both the first and last visits by lab staff qualified for blood drawing. Stool sample kits will be given to participants to collect at home (first sample returned via mail before start of intervention, second sample returned at final visit after intervention).
The primary outcome will be the difference between the probiotic vs. placebo groups in mean Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C) and mean Beck Depression Inventory 2nd edition (BDI-II) pre-/post-intervention. The primary analysis will be based on intention-to-treat. For other secondary outcomes, the between-group difference analysis will be applied to the fatigue, anxiety, PD motor function, and quality of life scores pre/post intervention, respectively. PD severity will be monitored using Parts I-IV of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Participants will be given a study journal to record their intervention doses, number of bowel movements, use of laxatives, and adverse events daily. Adverse events, tolerability and drop-out rates will be registered and overall rates compared between the intervention groups. Furthermore, differences and changes in blood markers and microbiome composition will be assessed.
- Conditions
- Parkinson Disease, Depression, PARKINSON DISEASE (Disorder)
- Being tested
- Probiotic, Placebo
- Keywords
- Parkinsons Disease, Depression, Probiotics, Gut Microbiome
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Ecologic® BARRIER 849
Oral probiotic delivered in powdered form.
PlaceboDietary supplement
Oral placebo delivered in powdered form.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58; ≥ 2,5*10^9 colony forming unit (CFU)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10^9 CFU/gram) per day. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
The Inventory for Depressive Symptomatology is a measure of depressive signs and symptoms administered by a trained clinician. The score range is 0-84 points, with a higher score indicating greater levels of depressive symptomatology.
Measured: 13 weeks
Beck Depression Inventory, 2nd Edition (BDI-II)
The Beck Depression Inventory is a self-reported 21-question multiple-choice self-report inventory on a scale from 0-63. A higher score indicates greater characteristic attitudes and symptoms of depression.
BDI-II is also used as a screening item for mild to moderate depression for this study.
Measured: 13 weeks
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
QIDS-SR is a 16-item, self-administered questionnaire used to assess the severity of depressive symptoms over the past 7 days, based on DSM-IV criteria. QIDS-SR is a shortened version of IDS-C, but QIDS-SR is self-rated (filled in the form of a questionnaire) and IDS-C is clinician-rated (administered as a clinical assessment), so using both assessments allows us to incorporate both self-rated and clinician-rated measures. The score range is 0-27 points, with a higher score indicating greater levels of depressive symptomatology.
Measured: 13 weeks
Secondary outcomes (7)
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders on a scale from 1 (strongly disagree) to 7 (strongly agree). The minimum score is 9 and the maximum score is 63. A higher score indicates greater fatigue severity.
Measured: 13 weeks
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment test is a one-page, 30-point assessment administered by trained individuals that is used for detecting mild cognitive impairment and dementia. Score may range from 0-30 points and a lower score may indicate greater cognitive impairment.
Measured: 13 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The Movement Disorder Society Unified Parkinson's Disease Rating Scale is a clinical assessment of motor and non-motor symptoms in individuals with Parkinson's Disease (PD). It consists of four subscales. Subscales 1, 3, and 4 are administered by a trained individual and subscale 2 is self-reported. Each item is rated from 0 to 4. The total score can range from 0-199, with a higher score indicating greater impairment in PD.
Measured: 13 weeks
Parkinson's Anxiety Scale (PAS)
The Parkinson's Anxiety Scale is a 12-point observer or patient-rated scale that has three subscales: persistent anxiety, episodic anxiety, and avoidance behaviour. It is rated using a Likert scale (0-4). Possible scores range from 0-48, with a higher score indicating greater severity of anxiety symptoms.
Measured: 13 weeks
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
The Parkinson's Disease Quality of Life Questionnaire is a self-reported questionnaire that assesses how often people affected by Parkinson's Disease (PD) experience difficulties across 8 dimensions of daily living. It consists of 39 items and is rated on a Likert scale (0-4). Each dimension's score can range from 0-100. A higher score indicates a worse quality of life.
Measured: 13 weeks
Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
The Parkinson's Disease - Cognitive Rating Scale (PD-CRS) is a cognitive scale specifically designed to capture the whole spectrum of cognitive functions impaired over the course of Parkinson's Disease (PD). This battery is composed of a total of 9 tasks explicitly designed for a brief and separate scoring of:
Frontal Subcortical tasks (sustained attention, working memory, alternating and action verbal fluency, clock drawing, immediate and delayed free recall verbal memory) and Posterior Cortical tasks (confrontation naming and clock copying).
Measured: 13 weeks
Parkinson's Disease - Cognitive Functional Rating Scale (PD-CFRS)
The PD-CFRS is a short Parkinson's Disease (PD) specific questionnaire, used to explore a wide range of functional aspects suspected to be sensitive to cognitive impairment in PD. All 12 questions explore, with some examples, whether or not the patient has had trouble performing specific activities in the past few weeks.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start20 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, triple-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Cresswell, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568498
- Sponsor's protocol ID
- H17-01853
- Acronym
- ProD
- Status last verified
- May 2026
- First submitted
- 15 Jun 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05568498
- Acronym / sponsor ID
- ProD / H17-01853
- Conditions
- Parkinson Disease, Depression, PARKINSON DISEASE (Disorder)
- Keywords
- Parkinsons Disease, Depression, Probiotics, Gut Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2022 (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 evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.
Detailed description
Parkinson's disease (PD) is a complex condition that carries a high burden of neuropsychiatric comorbidities. About a third of individuals living with PD have one or more depressive disorders, resulting in lower quality of life, greater care dependency, and increased caregiver burden. Gastrointestinal dysfunction is also very common in PD. Constipation is experienced by the vast majority of patients and often manifests years before onset of motor symptoms. Symptoms suggestive of irritable bowel syndrome (IBS) are also commonly found in PD. Increased intestinal permeability has been demonstrated in PD; impaired intestinal barrier function can lead to chronic systemic low-grade inflammation, which has been strongly associated with mood disorders. Several lines of evidence suggest a link between the gut microbiome and PD.
The microbiome has been linked to depression both in human and animal studies. Several studies have found beneficial effects of probiotics on mood disorders in non-PD populations, including stress and depressive behaviour in animal models, and sad mood reactivity and major depressive disorder (MDD) in humans.
In summary, given the high rate of depression in PD, the growing evidence that probiotics may improve depression and mood disorders in non-PD populations, and the strong links between the gut microbiome and PD, we will carry out a randomized, triple-blinded, placebo-controlled study into the use of a multi-strain probiotic to improve depression and PD.
Recruitment: Approximately 60 participants will be randomized to either the probiotic intervention arm or the placebo intervention arm. Participants will mainly be recruited from the Pacific Parkinson's Research Centre (PPRC) Movement Disorder Clinic at the University of British Columbia (UBC) in Vancouver.
Participants will receive a detailed description of the study and will need to provide informed consent for participation in the study. Participants will be screened for inclusion and exclusion criteria, which include completing screening questionnaires and reviewing medications/medical history.
Assessments: Clinical assessments of motor function, cognition and neuropsychiatric symptoms will be administered before the 12-week intervention phase, as well as following the 12-week intervention. Phone check-ins at weeks 4 and 8 during the intervention will be done to record adverse events and medication/lifestyle changes. Remote questionnaires will be sent to participants at every time point (visit 1, week 4 check-in, week 8 check-in, final visit). Blood samples and stool samples will be collected before and after the intervention. Blood (18mL) will be collected at both the first and last visits by lab staff qualified for blood drawing. Stool sample kits will be given to participants to collect at home (first sample returned via mail before start of intervention, second sample returned at final visit after intervention).
The primary outcome will be the difference between the probiotic vs. placebo groups in mean Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C) and mean Beck Depression Inventory 2nd edition (BDI-II) pre-/post-intervention. The primary analysis will be based on intention-to-treat. For other secondary outcomes, the between-group difference analysis will be applied to the fatigue, anxiety, PD motor function, and quality of life scores pre/post intervention, respectively. PD severity will be monitored using Parts I-IV of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Participants will be given a study journal to record their intervention doses, number of bowel movements, use of laxatives, and adverse events daily. Adverse events, tolerability and drop-out rates will be registered and overall rates compared between the intervention groups. Furthermore, differences and changes in blood markers and microbiome composition will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, triple-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticEcologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58; ≥ 2,5*10^9 colony forming unit (CFU)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10^9 CFU/gram) per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- Between the ages of 40-80 years
- Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
- Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
- Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices, vasectomy/tubal litigation, barrier methods and double barrier method) and must have negative pregnancy test results at screening and baseline
Key exclusion criteria (22 listed)
- Atypical Parkinsonism
- Active suicidality
- Active psychosis
- Cognitive score (MoCA) of < 21 in the "ON" state
- Severe depression (BDI-II score > 28 in the "ON" state)
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 |
|---|---|---|
| ProbioticAlso: Ecologic® BARRIER 849Oral probiotic delivered in powdered form. | Dietary supplement | Probiotic |
| PlaceboOral placebo delivered in powdered form. | Dietary supplement | Placebo |
Primary outcome
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
Time frame: 13 weeks
The Inventory for Depressive Symptomatology is a measure of depressive signs and symptoms administered by a trained clinician. The score range is 0-84 points, with a higher score indicating greater levels of depressive symptomatology.
Beck Depression Inventory, 2nd Edition (BDI-II)
Time frame: 13 weeks
The Beck Depression Inventory is a self-reported 21-question multiple-choice self-report inventory on a scale from 0-63. A higher score indicates greater characteristic attitudes and symptoms of depression. BDI-II is also used as a screening item for mild to moderate depression for this study.
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time frame: 13 weeks
QIDS-SR is a 16-item, self-administered questionnaire used to assess the severity of depressive symptoms over the past 7 days, based on DSM-IV criteria. QIDS-SR is a shortened version of IDS-C, but QIDS-SR is self-rated (filled in the form of a questionnaire) and IDS-C is clinician-rated (administered as a clinical assessment), so using both assessments allows us to incorporate both self-rated and clinician-rated measures. The score range is 0-27 points, with a higher score indicating greater levels of depressive symptomatology.
7 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: 13 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 13 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 13 weeks
Parkinson's Anxiety Scale (PAS)
Time frame: 13 weeks
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Time frame: 13 weeks
Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
Time frame: 13 weeks
Parkinson's Disease - Cognitive Functional Rating Scale (PD-CFRS)
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Parkinson Disease and Depression, run by University of British Columbia 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 22 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Leung, BSc (604-827-1905, Matthew.Leung@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C) (time frame: 13 weeks). The study lists 3 primary outcomes in all. 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 8 May 2026.