Treatment Resistant DepressionNCT03986658
Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Treatment Durations From Ten Days to One Day
A study testing Linear Asymmetric rTMS System in people with Treatment Resistant Depression, run by NeuroQore Inc. at 1 site in Canada.
Trial summary
This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Linear Asymmetric rTMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2025to Dec 2029
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
- Meets criteria for TRD:
- failed two adequate courses of antidepressant medication OR
- failed adequate course of medication AND one course of psychotherapy.
- Score of > 40 on Child Depression Rating Scale-Revised OR score of > 20 on Child Depression Inventory-2.
- Fluent in speaking and reading English.
Who cannot join
- Positive pregnancy test.
- Current or past: bipolar disorder, psychotic disorder, autism spectrum disorder, intellectual disability, substance use disorder, conduct disorder, as determined by a structured psychiatric interview.
- Medical illness that could lower the seizure threshold, e.g., epilepsy from any cause.
- Medications that could lower the seizure threshold or affect brain function.
- Psychotropic medications changed in two weeks prior to enrollment.
- Fails the TMS safety screening questionnaire.
Show all 9Show fewer
- Fails fMRI screening process.
- Left-handed (may indicate different cortical lateralization which could affect outcomes).
- Involuntarily committed to the hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Response Study of Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. In contrast, the First Dawn rTMS system by NeuroQore can sustain a repetitive linear asymmetric pulse. In addition, identification of rTMS treatment sites in adolescents with TRD most often relies on anatomic landmarks, but the First Dawn rTMS system utilizes personal fMRI data in a novel algorithm to determine where to apply the rTMS in each patient.
Based on adult data in healthy volunteers and patients with TRD, the investigators propose that the First Dawn rTMS system will be acceptable and well-tolerated by adolescents and will have minimal side effects. Please see https://clinicaltrials.gov/ct2/show/NCT02667041 for details on the completed pilot study in adults.
The investigators aim to investigate acceptability, tolerability, and side effects in groups of patients receiving treatment in numbers of sessions/day that are gradually accelerated over the course of the study. Results will be used to inform the development of a randomized controlled trial.
Read the detailed description
The 18 patients will be placed into 6 sub-groups sequentially as they are enrolled. All patients will receive a maximum of 30,000 pulses in their treatment course, as tolerated. The first group will receive daily sessions, similar to standard rTMS treatment. Each of the remaining groups will be set to receive more frequent sessions/day in decreasing numbers of days on a graduated schedule while holding the total number of pulses for each patient's treatment course at 30,000 pulses. in addition, the investigators will recruit one healthy volunteer to test fMRI server data transfer and analysis. This healthy volunteer will not receive rTMS.
Primary Objectives
The primary objectives of this study are to assess: 1) the feasibility of enrollment (number of patients who enroll divided by the number of patients approached), 2) study retention (number of patients completing the study divided by the number enrolled), and 3) AE/SE profile of the treatment at each protocol level and 4) patient experience in the study across the sample and within the sub-groups.
Secondary Objectives
The secondary objectives of this study are to: 1) evaluate daily changes in symptoms of depression and mental status; 2) evaluate fMRI changes in the LDLPFC after treatment; 3) evaluate post-treatment and 3-month changes in depression symptoms, global function, mental status, verbal memory.
- Conditions
- Treatment Resistant Depression
- Being tested
- Linear Asymmetric rTMS System
- Keywords
- Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS), Treatment-Resistant Depression, Adolescents
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Asymmetric rTMS SystemDevice
Linear Asymmetric rTMS System
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Experimental | Device: First Dawn rTMS System used in 18 patients divided into groups of 3. Each group will receive a different and gradually increasing frequency of treatment sessions/day (1-10) over a decreasing number of days (10-1). The total number of pulses for all levels will be 30,000. The use of each level will be dependent on tolerability and safety of the previous lower level, i.e., if one level is not tolerated well by a group, progression to the next level will not occur. Receives: Device: Linear Asymmetric rTMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Enrollment Rate
Number of patients who give consent divided by the number who are approached.
Measured: Through study completion, an average of 10 months
Patient Completion Rate
Number of patients who complete the study divided by the number of patients who enroll in the study.
Measured: Through study completion, an average of 10 months
Side Effects Profile
Measured with the rTMS Side Effect Questionnaire
Measured: Through study completion, an average of 10 months
Patient Experience
Measured with the Multi-Care Institute for Research and Innovation Research Participant Satisfaction Questionnaire
Measured: Through study completion, an average of 10 months
Secondary outcomes (5)
Change in self-reported MDD symptoms
Measured with the Child Depression Inventory-2.(CDI-2)
Measured: Change from baseline score to score at 3 months
Change in clinician-rated MDD symptoms
Measured with the Child Depression Rating Scale-Revised (CDRS-R)
Measured: Change from baseline score to score at 3 months
Change in function
Measured with the Children's Global Assessment Scale (C-GAS)
Measured: Change from baseline score to score at 3 months
Change in mental status
Measured with the Mini-Mental State Examination (MMSE)
Measured: Change from baseline score to score at 3 months
Change in short-term verbal memory
Measured with the Hopkins Verbal Learning Test-Revised (HLVT-R)
Measured: Change from baseline score to score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study startMay 2025 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: Due to a strategic decision by the sponsor, the study has been relocated to a different site, necessitating the withdrawal of this specific registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant 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
- Not applicable
- Intervention model
- Single group
- Model description
- rTMS
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroQore Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Eastern Ontario
- Responsible party
- Sponsor
- Investigators
- Kathleen Pajer, MD, Principal investigator, Children's Hospital of Eastern Ontario (CHEO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986658
- Sponsor's protocol ID
- CHEO19P1
- Status last verified
- Oct 2026
- First submitted
- 31 May 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: clintrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Study of Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
- ClinicalTrials.gov ID
- NCT03986658
- Acronym / sponsor ID
- CHEO19P1
- Conditions
- Treatment Resistant Depression
- Keywords
- Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS), Treatment-Resistant Depression, Adolescents
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a strategic decision by the sponsor, the study has been relocated to a different site, necessitating the withdrawal of this specific registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroQore Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of Eastern Ontario
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 Jun 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.
This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. In contrast, the First Dawn rTMS system by NeuroQore can sustain a repetitive linear asymmetric pulse. In addition, identification of rTMS treatment sites in adolescents with TRD most often relies on anatomic landmarks, but the First Dawn rTMS system utilizes personal fMRI data in a novel algorithm to determine where to apply the rTMS in each patient.
Based on adult data in healthy volunteers and patients with TRD, the investigators propose that the First Dawn rTMS system will be acceptable and well-tolerated by adolescents and will have minimal side effects. Please see https://clinicaltrials.gov/ct2/show/NCT02667041 for details on the completed pilot study in adults.
The investigators aim to investigate acceptability, tolerability, and side effects in groups of patients receiving treatment in numbers of sessions/day that are gradually accelerated over the course of the study. Results will be used to inform the development of a randomized controlled trial.
Detailed description
The 18 patients will be placed into 6 sub-groups sequentially as they are enrolled. All patients will receive a maximum of 30,000 pulses in their treatment course, as tolerated. The first group will receive daily sessions, similar to standard rTMS treatment. Each of the remaining groups will be set to receive more frequent sessions/day in decreasing numbers of days on a graduated schedule while holding the total number of pulses for each patient's treatment course at 30,000 pulses. in addition, the investigators will recruit one healthy volunteer to test fMRI server data transfer and analysis. This healthy volunteer will not receive rTMS.
Primary Objectives
The primary objectives of this study are to assess: 1) the feasibility of enrollment (number of patients who enroll divided by the number of patients approached), 2) study retention (number of patients completing the study divided by the number enrolled), and 3) AE/SE profile of the treatment at each protocol level and 4) patient experience in the study across the sample and within the sub-groups.
Secondary Objectives
The secondary objectives of this study are to: 1) evaluate daily changes in symptoms of depression and mental status; 2) evaluate fMRI changes in the LDLPFC after treatment; 3) evaluate post-treatment and 3-month changes in depression symptoms, global function, mental status, verbal memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- rTMS
| Arm | Type | Receives |
|---|---|---|
| Adolescents | Experimental | Device: Linear Asymmetric rTMS SystemDevice: First Dawn rTMS System used in 18 patients divided into groups of 3. Each group will receive a different and gradually increasing frequency of treatment sessions/day (1-10) over a decreasing number of days (10-1). The total number of pulses for all levels will be 30,000. The use of each level will be dependent on tolerability and safety of the previous lower level, i.e., if one level is not tolerated well by a group, progression to the next level will not occur. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
- Meets criteria for TRD:
- Score of > 40 on Child Depression Rating Scale-Revised OR score of > 20 on Child Depression Inventory-2.
- Fluent in speaking and reading English.
Key exclusion criteria (9 listed)
- Positive pregnancy test.
- Current or past: bipolar disorder, psychotic disorder, autism spectrum disorder, intellectual disability, substance use disorder, conduct disorder, as determined by a structured psychiatric interview.
- Medical illness that could lower the seizure threshold, e.g., epilepsy from any cause.
- Medications that could lower the seizure threshold or affect brain function.
- Psychotropic medications changed in two weeks prior to enrollment.
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 |
|---|---|---|
| Linear Asymmetric rTMS SystemLinear Asymmetric rTMS System | Device | Adolescents |
Primary outcome
Patient Enrollment Rate
Time frame: Through study completion, an average of 10 months
Number of patients who give consent divided by the number who are approached.
Patient Completion Rate
Time frame: Through study completion, an average of 10 months
Number of patients who complete the study divided by the number of patients who enroll in the study.
Side Effects Profile
Time frame: Through study completion, an average of 10 months
Measured with the rTMS Side Effect Questionnaire
Patient Experience
Time frame: Through study completion, an average of 10 months
Measured with the Multi-Care Institute for Research and Innovation Research Participant Satisfaction Questionnaire
5 secondary outcomes
Change in self-reported MDD symptoms
Time frame: Change from baseline score to score at 3 months
Change in clinician-rated MDD symptoms
Time frame: Change from baseline score to score at 3 months
Change in function
Time frame: Change from baseline score to score at 3 months
Change in mental status
Time frame: Change from baseline score to score at 3 months
Change in short-term verbal memory
Time frame: Change from baseline score to score at 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. clintrials.gov
Related trials for Treatment Resistant Depression
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
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.
Kathleen Pajer, MD principal investigator
Children's Hospital of Eastern Ontario (CHEO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Asymmetric rTMS System in people with Treatment Resistant Depression, run by NeuroQore Inc. 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 2 Nov 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Enrollment Rate (time frame: Through study completion, an average of 10 months). 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?
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 2 Nov 2026.