Major Depressive EpisodeNCT04142996
Comparing Uni- and Bi-lateral TBS in Major Depression
A study testing Theta burst stimulation in people with Major Depressive Episode, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2019to Sep 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary and competent to consent to study,
- female or male aged 18 years old or older,
- can speak and read English and/or French
- primary and/or predominant diagnosis of major depressive episode without psychotic features in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),
- depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,
- moderate symptoms in the current depressive episode as indexed by a score of at least 15 at the 17-item Hamilton Rating Scale for Depression (HRSD-17),
Show all 10Show fewer
- have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,
- are able to adhere to treatment schedule,
- have received a stable psychiatric medication (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,
- have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if are aged ≥ 65.
Who cannot join
- current or past (< 3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion
- current use of illegal substances or recreational cannabis
- have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
- organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician
- acute suicidality or threat to life from self-neglect,
- are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment,
Show all 11Show fewer
- have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),
- unwilling to maintain current antidepressant regimen,
- are taking more than 1 mg of lorazepam or equivalent,
- any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,
- have failed a course of electroconvulsive therapy (ECT) within the current depressive episode due to the lower likelihood of response to rTMS.If they have had failed ECT in the past, this does not exclude them
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z 7K4
Sara Tremblay, 613-722-6521 ext. 6227, Sara.Tremblay@theroyal.ca
About this study
Official title: A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily session delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm which reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. However, it remains to be determined if applying TBS to both sides of the frontal cortex (i.e. bilateral TBS) is more efficient than delivering it to only one side (i.e. unilateral TBS). In addition, it is difficult to predict treatment response as there is a lack of tools to identify potential responders early on in the treatment phase. Finally, the effects of rTMS are known to last up to 12 months after the treatment. To avoid relapse, a maintenance phase is typically introduced after treatment in which treatment sessions are delivered at a gradually decreasing rate. This study proposes to bridge these gaps by conducting a randomized double-blinded naturalistic superiority trial in which the efficacy of bilateral and unilateral TBS will be compared in individuals with a diagnosis of major depressive episodes. Neurobiological markers of response will be assessed at different time points. In people that respond to treatment, a 6-month maintenance phase will be conducted using a flexible schedule.
The study has four primary aims:
- To compare the efficacy of bilateral and unilateral TBS on symptoms of depression, as well as rates of remission and response
- To investigate how unilateral and bilateral TBS modulates brain activity in the dorsolateral prefrontal cortex (DLPFC) using interleaved TMS-EEG
- To investigate neural predictors of the clinical response to TBS.
- To assess the efficacy of a flexible schedule of maintenance on a period of 6 months on symptoms of depression and rate of relapse.
TREATMENT PHASE TBS treatment will be administered 5 days/week (on weekdays) over a first phase of 4 weeks (20 sessions). If remission is achieved (Hamilton Rating Scale for Depression-17 score < 8), treatment will cease and the patient will move on to the maintenance phase. Non-remitters will receive a second phase of treatment, consisting of an additional 2 weeks (10 sessions, for a total of 30). After 6 weeks, all responders may move on to the maintenance phase.
MAINTENANCE PHASE The maintenance phase will be of 6 months duration from the end of the randomized treatment. For each TBS condition, responders will be assigned to a flexible maintenance protocol based on symptom emergence. Participants will receive a fixed 2x/week schedule for the month 1. For month 2 and 3, a brief weekly assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions in the week. For month 4 and 5, a bimonthly assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions over the two weeks. For month 6, one brief assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions in the month.
- Conditions
- Major Depressive Episode
- Being tested
- Theta burst stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulationDevice
Cool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
| Study group | Role | What they receive |
|---|---|---|
| Unilateral TBS | Active comparator | Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved). Receives: Device: Theta burst stimulation |
| Bilateral TBS | Active comparator | Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved). Receives: Device: Theta burst stimulation |
| Maintenance Phase: Flexible | Active comparator | The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis. Receives: Device: Theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Measured: Week 6
Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Measured: End of treatment phase (week 4 or 6)
Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome
Measured: 6 months
Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Measured: 6 months
Secondary outcomes (4)
Response - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean the Quick Inventory of Depression Symptomology-Self Report score. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Measured: Week 6
Remission - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Remission will be defined as a Quick Inventory of Depression Symptomology-Self Report score ≤ 6. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome
Measured: End of treatment phase (week 4 or 6)
Response - Maintenance Phase (Quick Inventory of Depression Symptomology-Self Report)
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean the Quick Inventory of Depression Symptomology-Self Report score. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Measured: 6 months
Remission - Maintenance Phase Quick Inventory of Depression Symptomology-Self Report)
Remission will be defined as a Quick Inventory of Depression Symptomology-Self Report score ≤ 6. The minimum value is 0 and the maximum value is 48. A higher score indicates a negative outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start12 Dec 2019
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
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 Major Depressive EpisodeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Tremblay, PhD, Principal investigator, The Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142996
- Sponsor's protocol ID
- 2019017
- Status last verified
- Nov 2023
- First submitted
- 15 Oct 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data collected from this study (IPD) will be de-identified for all parties who have permission to access it. This de-identified data may be shared with other researchers at the Royal's Institute of Mental Health Research. De-identified may be shared with the public only upon request. Please note that all data that has the potential of revealing participants' identity will NOT be used to shared.
Publications
Watson M, Chaves AR, Gebara A, Desforges M, Broomfield A, Landry N, Lemoyne A, Shim S, Drodge J, Cuda J, Kiaee N, Nasr Y, Carleton C, Daskalakis ZJ, Taylor R, Tuominen L, Brender R, Antochi R, McMurray L, Tremblay S. A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression - the U-B-D study protocol. BMC Psychiatry. 2023 Oct 10;23(1):739. doi: 10.1186/s12888-023-05243-4.
PubMed 37817124
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression
- ClinicalTrials.gov ID
- NCT04142996
- Acronym / sponsor ID
- 2019017
- Conditions
- Major Depressive Episode
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Oct 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.
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical treatments involve 30 to 45 minutes daily session delivered over 4 to 6 weeks. Recent technical advances allowed the development of theta burst stimulation (TBS), a novel rTMS paradigm which reduces daily sessions to 3 to 4 minutes while maintaining the same clinical efficacy. However, it remains to be determined if applying TBS to both sides of the frontal cortex (i.e. bilateral TBS) is more efficient than delivering it to only one side (i.e. unilateral TBS). In addition, it is difficult to predict treatment response as there is a lack of tools to identify potential responders early on in the treatment phase. Finally, the effects of rTMS are known to last up to 12 months after the treatment. To avoid relapse, a maintenance phase is typically introduced after treatment in which treatment sessions are delivered at a gradually decreasing rate. This study proposes to bridge these gaps by conducting a randomized double-blinded naturalistic superiority trial in which the efficacy of bilateral and unilateral TBS will be compared in individuals with a diagnosis of major depressive episodes. Neurobiological markers of response will be assessed at different time points. In people that respond to treatment, a 6-month maintenance phase will be conducted using a flexible schedule.
The study has four primary aims:
- To compare the efficacy of bilateral and unilateral TBS on symptoms of depression, as well as rates of remission and response
- To investigate how unilateral and bilateral TBS modulates brain activity in the dorsolateral prefrontal cortex (DLPFC) using interleaved TMS-EEG
- To investigate neural predictors of the clinical response to TBS.
- To assess the efficacy of a flexible schedule of maintenance on a period of 6 months on symptoms of depression and rate of relapse.
TREATMENT PHASE TBS treatment will be administered 5 days/week (on weekdays) over a first phase of 4 weeks (20 sessions). If remission is achieved (Hamilton Rating Scale for Depression-17 score < 8), treatment will cease and the patient will move on to the maintenance phase. Non-remitters will receive a second phase of treatment, consisting of an additional 2 weeks (10 sessions, for a total of 30). After 6 weeks, all responders may move on to the maintenance phase.
MAINTENANCE PHASE The maintenance phase will be of 6 months duration from the end of the randomized treatment. For each TBS condition, responders will be assigned to a flexible maintenance protocol based on symptom emergence. Participants will receive a fixed 2x/week schedule for the month 1. For month 2 and 3, a brief weekly assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions in the week. For month 4 and 5, a bimonthly assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions over the two weeks. For month 6, one brief assessment (Hamilton Rating Scale for Depression-17 score) will be conducted in which it will be determined if they will receive 0, 1 or 2 sessions in the month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral TBS | Active comparator | Device: Theta burst stimulationIntermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved). |
| Bilateral TBS | Active comparator | Device: Theta burst stimulationIntermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved). |
| Maintenance Phase: Flexible | Active comparator | Device: Theta burst stimulationThe flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- voluntary and competent to consent to study,
- female or male aged 18 years old or older,
- can speak and read English and/or French
- primary and/or predominant diagnosis of major depressive episode without psychotic features in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),
- depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,
Key exclusion criteria (11 listed)
- current or past (< 3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion
- current use of illegal substances or recreational cannabis
- have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
- organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician
- acute suicidality or threat to life from self-neglect,
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 |
|---|---|---|
| Theta burst stimulationCool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark) | Device | Bilateral TBS, Maintenance Phase: Flexible, Unilateral TBS |
Primary outcome
Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)
Time frame: Week 6
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)
Time frame: End of treatment phase (week 4 or 6)
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)
Time frame: 6 months
Response to treatment will be defined as a > 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome
Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)
Time frame: 6 months
Remission will be defined as a Hamilton Rating Scale for Depression-17 score ≤ 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.
4 secondary outcomes
Response - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Time frame: Week 6
Remission - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Time frame: End of treatment phase (week 4 or 6)
Response - Maintenance Phase (Quick Inventory of Depression Symptomology-Self Report)
Time frame: 6 months
Remission - Maintenance Phase Quick Inventory of Depression Symptomology-Self Report)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 37817124Watson M, Chaves AR, Gebara A, Desforges M, Broomfield A, Landry N, Lemoyne A, Shim S, Drodge J, Cuda J, Kiaee N, Nasr Y, Carleton C, Daskalakis ZJ, Taylor R, Tuominen L, Brender R, Antochi R, McMurray L, Tremblay S. A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression - the U-B-D study protocol. BMC Psychiatry. 2023 Oct 10;23(1):739. doi: 10.1186/s12888-023-05243-4.
- Individual participant dataSharing planned: Yes. All Individual Participant Data collected from this study (IPD) will be de-identified for all parties who have permission to access it. This de-identified data may be shared with other researchers at the Royal's Institute of Mental Health Research. De-identified may be shared with the public only upon request. Please note that all data that has the potential of revealing participants' identity will NOT be used to shared.
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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.
Sara Tremblay, PhD principal investigator
The Royal Ottawa Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst stimulation in people with Major Depressive Episode, run by The Royal Ottawa Mental Health Centre 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 10 inclusion and 11 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 4 Dec 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Stacey Shim, MSc (613-722-6521 ext. 6356, stacey.shim@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score) (time frame: Week 6). The study lists 4 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 NCT04142996, 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 4 Dec 2023.