DepressionNCT06528938
Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
A study testing Theta Burst Stimulation in people with Depression and Depressive Disorder, Major, 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), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Depression, Depressive Disorder, Major
- 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
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Aug 2027
- Phase
- Interventional
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary and competent to consent.
- Ages 16-19 years old.
- Can speak and read English.
- Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
- Moderate symptoms in the current depressive episode, indexed by a score of at least 40 on the Children's Depression Rating Scale Revised for depression (CDRS-R).
- Are able to adhere to the treatment schedule.
- Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial.
Who cannot join
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or past substance (< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past 3 months, moderate to severe would be an exclusion.
- Current use of illegal substances or cannabis confirmed by urine screening test.
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
- Acute suicidality or life-threatening due to self-neglect.
Show all 11Show fewer
- Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).
- Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
- Unwilling to maintain the current antidepressant regimen.
- Taking more than 1 mg/day of lorazepam or equivalent.
- Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.
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
The Royal's Institute of Mental Health Research
Ottawa, Ontario, K1Z 7K4
Sara Tremblay, PhD, 613-722-6521 ext. 6227, Sara.Tremblay@theroyal.ca
About this study
Official title: Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
Read the detailed description
Recently the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) has significantly improved for Treatment-Resistant Depression (TRD) in adults and promising evidence suggesting safety and efficacy of rTMS in adolescents. These youth studies currently use outdated stimulation protocols, with most of them using treatments on a once/daily schedule. Given the prevalence, morbidity, and mortality associated with depression in adolescents, and considering that over 40% of adolescents do not respond to medications, a randomized controlled trial (RCT) to establish the safety and efficacy of new rTMS protocols for difficult-to-treat depression in adolescents is desperately needed.
This open-label randomized controlled trial will compare accelerated intermittent theta burst stimulation (iTBS) and standard once a day iTBS in adolescents with major depressive disorder (MDD). For this pilot trial, 10 adolescents (5 females, 5 males) with treatment-resistant depression will be recruited. Each participant will undergo a 30-40-minute magnetic resonance imaging (MRI) scan, after which they will receive iTBS applied to the left dorsolateral prefrontal cortex (DLPFC) once a day for 6 weeks (standard treatment) or for an accelerated duration of 3 times a day for 2 weeks. Symptoms will be assessed through clinical assessments as well as self-report questionnaires. Prior to treatment start each participant will complete the clinical assessments as well as the self-report questionnaires for a baseline measurement. The self-report measures will be completed every 5th treatment (total of 7 times including baseline). The clinical assessments will be completed after the 15th and 30th treatment, as well as 2-,4-, and 12-weeks post treatment course (total of 6 times including baseline). The main outcome of this trial is a clinical response rate which will be defined as a ≥ 50% reduction in depressive symptoms based off of the Children's Depression Rating Scale Revised for depression (CDRS-R). The secondary outcome of this trial is suicidal ideation which will be measured by the Beck Scale for Suicidal Ideation (BSS), as well as several other outcomes such as anxiety, sleep quality, physical activity and stress. The ultimate goal of this study is to provide initial evidence for conducting a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of an fMRI-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
- Conditions
- Depression, Depressive Disorder, Major
- Being tested
- Theta Burst Stimulation
- Keywords
- Accelerated rTMS, repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Depression, Depressive Disorder, Major
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) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
| Study group | Role | What they receive |
|---|---|---|
| Accelerated iTBS | Active comparator | Intermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks). Receives: Device: Theta Burst Stimulation |
| Standard iTBS | Active comparator | Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks). Receives: Device: Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents.
Clinical response will be defined as a ≥ 50% reduction in depressive symptoms based on the Children's Depression Rating Scale Revised for depression (CDRS-R). The CDRS-R is a clinician-evaluated instrument consisting of 17 items used to measure the severity of depressive episodes in a pediatric population in children 6 to 12 years of age that has been shown to be applicable in adolescents as well. The overall score ranges from 17 to 113, where scores of ≥40 suggest moderate to severe depression and ≤28 is defined as remission or asymptomatic. In this study, a response to treatment will be defined as a reduction of 50% or more on the overall CDRS-R score at the post-intervention assessment (post-treatment 30).
Measured: Administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
Secondary outcomes (1)
Change in self-reported suicidal ideation as measured by Beck Scale for Suicidal Ideation (BSS).
The BSS is a self-administered questionnaire consisting of 19 items that assesses an individual's presence of suicidal ideations and intensity. Each item is rated on a scale of 0 to 2, with a possible total score ranging from 0 to 38. Several other questionnaires addressing anxiety, sleep quality, physical activity and stress, among others, will be administered.
Measured: Administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (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.
- 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
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke
- Responsible party
- Principal investigator, Sara Tremblay, The Royal Ottawa Mental Health Centre
- Investigators
- Sara Tremblay, PhD, Principal investigator, The Royal's Institute of Mental Health ResearchJean-François Lepage, PhD, Principal investigator, Sherbrooke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528938
- Sponsor's protocol ID
- 0047
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2024
- Last updated
- 1 Oct 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents
- ClinicalTrials.gov ID
- NCT06528938
- Acronym / sponsor ID
- 0047
- Conditions
- Depression, Depressive Disorder, Major
- Keywords
- Accelerated rTMS, repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Collaborators
- Université de Sherbrooke
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 30 Jul 2024 (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), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
Detailed description
Recently the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) has significantly improved for Treatment-Resistant Depression (TRD) in adults and promising evidence suggesting safety and efficacy of rTMS in adolescents. These youth studies currently use outdated stimulation protocols, with most of them using treatments on a once/daily schedule. Given the prevalence, morbidity, and mortality associated with depression in adolescents, and considering that over 40% of adolescents do not respond to medications, a randomized controlled trial (RCT) to establish the safety and efficacy of new rTMS protocols for difficult-to-treat depression in adolescents is desperately needed.
This open-label randomized controlled trial will compare accelerated intermittent theta burst stimulation (iTBS) and standard once a day iTBS in adolescents with major depressive disorder (MDD). For this pilot trial, 10 adolescents (5 females, 5 males) with treatment-resistant depression will be recruited. Each participant will undergo a 30-40-minute magnetic resonance imaging (MRI) scan, after which they will receive iTBS applied to the left dorsolateral prefrontal cortex (DLPFC) once a day for 6 weeks (standard treatment) or for an accelerated duration of 3 times a day for 2 weeks. Symptoms will be assessed through clinical assessments as well as self-report questionnaires. Prior to treatment start each participant will complete the clinical assessments as well as the self-report questionnaires for a baseline measurement. The self-report measures will be completed every 5th treatment (total of 7 times including baseline). The clinical assessments will be completed after the 15th and 30th treatment, as well as 2-,4-, and 12-weeks post treatment course (total of 6 times including baseline). The main outcome of this trial is a clinical response rate which will be defined as a ≥ 50% reduction in depressive symptoms based off of the Children's Depression Rating Scale Revised for depression (CDRS-R). The secondary outcome of this trial is suicidal ideation which will be measured by the Beck Scale for Suicidal Ideation (BSS), as well as several other outcomes such as anxiety, sleep quality, physical activity and stress. The ultimate goal of this study is to provide initial evidence for conducting a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of an fMRI-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Active comparator | Device: Theta Burst StimulationIntermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks). |
| Standard iTBS | Active comparator | Device: Theta Burst StimulationIntermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks). |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Voluntary and competent to consent.
- Ages 16-19 years old.
- Can speak and read English.
- Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
Key exclusion criteria (11 listed)
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or past substance (< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past 3 months, moderate to severe would be an exclusion.
- Current use of illegal substances or cannabis confirmed by urine screening test.
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
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) with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark) | Device | Accelerated iTBS, Standard iTBS |
Primary outcome
Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents.
Time frame: Administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
Clinical response will be defined as a ≥ 50% reduction in depressive symptoms based on the Children's Depression Rating Scale Revised for depression (CDRS-R). The CDRS-R is a clinician-evaluated instrument consisting of 17 items used to measure the severity of depressive episodes in a pediatric population in children 6 to 12 years of age that has been shown to be applicable in adolescents as well. The overall score ranges from 17 to 113, where scores of ≥40 suggest moderate to severe depression and ≤28 is defined as remission or asymptomatic. In this study, a response to treatment will be defined as a reduction of 50% or more on the overall CDRS-R score at the post-intervention assessment (post-treatment 30).
1 secondary outcome
Change in self-reported suicidal ideation as measured by Beck Scale for Suicidal Ideation (BSS).
Time frame: Administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.
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 1 Oct 2026.
- 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.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Sara Tremblay, PhD principal investigator
The Royal's Institute of Mental Health Research
Jean-François Lepage, PhD principal investigator
Sherbrooke University
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 Depression and Depressive Disorder, Major, 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 8 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: looking for participants now, as of the sponsor's last update on 1 Oct 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. 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?
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 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?
Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents. (time frame: Administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.). 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 1 Oct 2026.