Major Depressive DisorderpaiTBS-KIDNCT06523439
Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents
A study testing MagPro X100 edition (MagVenture, Skovlunde, Denmark) in people with Major Depressive Disorder and Depression in Adolescence, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS)-is effective as a first-line… Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Major Depressive Disorder, Depression in Adolescence, Depression
- What is being tested?
- MagPro X100 edition (MagVenture, Skovlunde, Denmark)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Dec 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or Female, between the ages of 13 and 20 at the time of screening.
- Able to read, understand, and provide written, dated assent and/or consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- No prior major depressive episodes (MDEs) as determined by MINI-KID
- CDRS-R score of ≥40 at screening (Visit 1).
- Treatment-naive as determined by the ATHF (no adequate antidepressant trials prior to screening defined as fewer than 12 weeks of antidepressant medication in the past 2 years and fewer than 10 psychotherapy sessions for depression in the past year; willingness to taper medications and stop psychotherapy if recently started and within the window defined above.)
Show all 10Show fewer
- TMS naive.
- Access to ongoing psychiatric care before and after completion of the study.
- In good general health, as evidenced by medical history.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
Who cannot join
- Pregnancy
- High-risk for suicide or active suicidal ideation as determined by clinical interview
- The presence or diagnosis of prominent anxiety disorder, or dysthymia (>4 on SAPAS; >16 on GAD-7)
- Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
- Current mania or psychosis
- Bipolar Affective Disorder and/or primary psychotic disorders.
Show all 20Show fewer
- Autism Spectrum disorder or Intellectual Disability
- A diagnosis of obsessive-compulsive disorder (OCD)
- Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
- Urine screening test positive for illicit substances.
- Any history of ECT (greater than 8 sessions) without meeting responder criteria
- Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
- History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
- Untreated or insufficiently treated endocrine disorder.
- Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
- Contraindications to MRI (ferromagnetic metal in their body).
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)
- Treatment with another investigational drug or other intervention within the study period.
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dell Medical School at University of Texas at Austin
Austin, Texas, 78731
Elyse Lemke, 512-495-5566, elyse.lemke@austin.utexas.edu
Psychclinicaltrials@austin.utexas.edu
About this study
Official title: Investigating a Truncated Version of paiTBS in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial
This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS)-is effective as a first-line therapy in treating adolescents aged 13-20 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.
The main questions this trial aims to answer are:
Read more
- Does aiTBS relieve symptoms of depression as a first-line therapy in adolescents?
- Is aiTBS a feasible option as a first-line treatment for adolescent depression?
Researchers will measure the depression symptoms in adolescent participants before and after aiTBS. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.
Adolescent participants will:
- Remain antidepressant-free throughout the study period of 6-7 weeks.
- Receive an fMRI of their head for precision targeting
- Receive 5 days of aiTBS
Read the detailed description
This single-site open-label clinical trial aims to test the safety and efficacy of precision accelerated intermittent theta burst stimulation (paiTBS) in treatment-naive adolescents with major depressive disorder (MDD) who remain antidepressant-free throughout the treatment. The paiTBS protocol, or a truncated version (5 or 10 applications per day to a customized target within the left dorsolateral prefrontal cortex [L-DLPFC] identified with fMRI for five consecutive days), in combination with MNS software will be delivered to each adolescent participant. Changes in depressive symptoms will be measured at baseline and two follow up visits. Additionally, parents and adolescents will answer questions regarding their preference for paiTBS as a first-line treatment option for MDD.
The hypothesis is that adolescent participants receiving paiTBS or the truncated version will demonstrate similar response and remission rates that are comparable to aiTBS trials in adults (80-90%) as measured by the Childhood Depression Rating Scale (CDRS) and Hamilton Depression Rating Scale.
The primary objective of this study is to determine the efficacy of active paiTBS in reducing symptoms of depression as measured by the CDRS at the one-month follow up time point.
The study will enroll approximately 40 participants and employ a two-arm design with 20 participants per arm. The target population is adolescents of all genders and ethnicities who are between 13 and 20 years of age with a diagnosis of MDD experiencing their first major depressive episode who have not received a full course of prior treatment and who are otherwise in good general health. Participants must be without contraindications to Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS) and must be able to attend all study visits.
This study will deliver paiTBS via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 5 or 10 daily sessions (25 or 50 total over 5-days) of paiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
- Conditions
- Major Depressive Disorder, Depression in Adolescence, Depression, Major Depressive Episode
- Being tested
- MagPro X100 edition (MagVenture, Skovlunde, Denmark)
- Keywords
- Stanford Accelerated Intelligent Neuromodulation Therapy, SAINT, Transcranial Magnetic Stimulation, Accelerated Theta Burst Stimulation, Accelerated Intermittent Theta Burst Stimulation, TMS, TMS in Adolescents
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro X100 edition (MagVenture, Skovlunde, Denmark)Device
10 daily sessions (50 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
MagPro X100 edition (MagVenture, Skovlunde, Denmark)Device
5 daily sessions (25 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
| Study group | Role | What they receive |
|---|---|---|
| Full-Dose paiTBS | Active comparator | 10 daily sessions (50 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). Receives: Device: MagPro X100 edition (MagVenture, Skovlunde, Denmark) |
| Half-Dose paiTBS | Experimental | 5 daily sessions (25 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). Receives: Device: MagPro X100 edition (MagVenture, Skovlunde, Denmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
Seventeen item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in adolescents with depression.
The investigators will assess the difference in CDRS-R scores/remission rates between the full-dose paiTBS group compared to those who received half-dose paiTBS at the one-month follow up visit.
Measured: Baseline, One Month Follow Up Visit
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
The investigators will assess the difference in CDRS-R response rates (reduction >50% of CDRS-R baseline score) between the full-dose aiTBS group compared to those who received half-dose aiTBS.
Measured: Baseline, One Month Follow Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Magnus Medical
- Responsible party
- Principal investigator, Sean O'Sullivan, University of Texas at Austin
- Investigators
- Sean J O'Sullivan, M.D., Ph. D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523439
- Sponsor's protocol ID
- NECMHR01-FY24-032
- Acronym
- paiTBS-KID
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Truncated Version of paiTBS in Treatment-Naive Adolescents With Depression: An Open-Label Acceptability Trial
- ClinicalTrials.gov ID
- NCT06523439
- Acronym / sponsor ID
- paiTBS-KID / NECMHR01-FY24-032
- Conditions
- Major Depressive Disorder, Depression in Adolescence, Depression, Major Depressive Episode
- Keywords
- Stanford Accelerated Intelligent Neuromodulation Therapy, SAINT, Transcranial Magnetic Stimulation, Accelerated Theta Burst Stimulation, Accelerated Intermittent Theta Burst Stimulation, TMS, TMS in Adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Magnus Medical
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 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.
This is a single-site open-label clinical trial of fMRI-guided accelerated intermittent theta burst stimulation. The goal of this clinical trial is to learn if a new form of transcranial magnetic stimulation (TMS)-known generally as accelerated intermittent theta burst stimulation (aiTBS)-is effective as a first-line therapy in treating adolescents aged 13-20 years-old in their first episode of depression who have not undergone a full course of depression treatment prior to starting the trial and who remain antidepressant-free throughout the trial.
The main questions this trial aims to answer are:
- Does aiTBS relieve symptoms of depression as a first-line therapy in adolescents?
- Is aiTBS a feasible option as a first-line treatment for adolescent depression?
Researchers will measure the depression symptoms in adolescent participants before and after aiTBS. Parents of the adolescent participant will also participate in the study providing information about their experience and preference for TMS as a first-line treatment.
Adolescent participants will:
- Remain antidepressant-free throughout the study period of 6-7 weeks.
- Receive an fMRI of their head for precision targeting
- Receive 5 days of aiTBS
Detailed description
This single-site open-label clinical trial aims to test the safety and efficacy of precision accelerated intermittent theta burst stimulation (paiTBS) in treatment-naive adolescents with major depressive disorder (MDD) who remain antidepressant-free throughout the treatment. The paiTBS protocol, or a truncated version (5 or 10 applications per day to a customized target within the left dorsolateral prefrontal cortex [L-DLPFC] identified with fMRI for five consecutive days), in combination with MNS software will be delivered to each adolescent participant. Changes in depressive symptoms will be measured at baseline and two follow up visits. Additionally, parents and adolescents will answer questions regarding their preference for paiTBS as a first-line treatment option for MDD.
The hypothesis is that adolescent participants receiving paiTBS or the truncated version will demonstrate similar response and remission rates that are comparable to aiTBS trials in adults (80-90%) as measured by the Childhood Depression Rating Scale (CDRS) and Hamilton Depression Rating Scale.
The primary objective of this study is to determine the efficacy of active paiTBS in reducing symptoms of depression as measured by the CDRS at the one-month follow up time point.
The study will enroll approximately 40 participants and employ a two-arm design with 20 participants per arm. The target population is adolescents of all genders and ethnicities who are between 13 and 20 years of age with a diagnosis of MDD experiencing their first major depressive episode who have not received a full course of prior treatment and who are otherwise in good general health. Participants must be without contraindications to Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (TMS) and must be able to attend all study visits.
This study will deliver paiTBS via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 5 or 10 daily sessions (25 or 50 total over 5-days) of paiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded
| Arm | Type | Receives |
|---|---|---|
| Full-Dose paiTBS | Active comparator | Device: MagPro X100 edition (MagVenture, Skovlunde, Denmark)10 daily sessions (50 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). |
| Half-Dose paiTBS | Experimental | Device: MagPro X100 edition (MagVenture, Skovlunde, Denmark)5 daily sessions (25 total over 5-days) of paiTBS stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Male or Female, between the ages of 13 and 20 at the time of screening.
- Able to read, understand, and provide written, dated assent and/or consent prior to screening. Proficiency in English sufficient to complete questionnaires and follow instructions during aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- Diagnosed with Major Depressive Disorder (MDD) with a current Major Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- No prior major depressive episodes (MDEs) as determined by MINI-KID
- CDRS-R score of ≥40 at screening (Visit 1).
Key exclusion criteria (20 listed)
- Pregnancy
- High-risk for suicide or active suicidal ideation as determined by clinical interview
- The presence or diagnosis of prominent anxiety disorder, or dysthymia (>4 on SAPAS; >16 on GAD-7)
- Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
- Current mania or psychosis
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 |
|---|---|---|
| MagPro X100 edition (MagVenture, Skovlunde, Denmark)10 daily sessions (50 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). | Device | Full-Dose paiTBS |
| MagPro X100 edition (MagVenture, Skovlunde, Denmark)5 daily sessions (25 total over 5-days) of aiTBS (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds) guided by MNS, delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be delivered at 90% of the resting motor threshold (with depth correction to account for the distance between the scalp and cortex). | Device | Half-Dose paiTBS |
Primary outcome
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
Time frame: Baseline, One Month Follow Up Visit
Seventeen item diagnostic questionnaire which psychiatrists use to measure the severity of depressive symptoms in adolescents with depression. The investigators will assess the difference in CDRS-R scores/remission rates between the full-dose paiTBS group compared to those who received half-dose paiTBS at the one-month follow up visit.
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates
Time frame: Baseline, One Month Follow Up Visit
The investigators will assess the difference in CDRS-R response rates (reduction >50% of CDRS-R baseline score) between the full-dose aiTBS group compared to those who received half-dose aiTBS.
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 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
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
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Sean J O'Sullivan, M.D., Ph. D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro X100 edition (MagVenture, Skovlunde, Denmark) in people with Major Depressive Disorder and Depression in Adolescence, run by University of Texas at Austin at 1 site in United States.
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 20 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 19 Aug 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 United States. 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 Daniella Santos (512-495-5566, daniella.santos@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Depression Rating Scale-Revised (CDRS-R) Remission Rates (time frame: Baseline, One Month Follow Up Visit). The study lists 2 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 19 Aug 2026.