Major Depressive DiorderNCT06728280
Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder
A study testing deep transcranial magnetic stimulation with H1coil and deep transcranial magnetic stimulation with H7 coil in people with Major Depressive Diorder, run by Zhifen Liu at 2 sites in China.
Trial summary
The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil. The main questions it aims to answer are: Type of study: Clinical trial. Read more about this study
- Who is it for?
- Ages 11 to 23 years
- Conditions the study is for
- Major Depressive Diorder
- What is being tested?
- deep transcranial magnetic stimulation with H1coil and deep transcranial magnetic stimulation with H7 coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to 30 Jun 2026
- 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 11 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of all genders, aged between 11 and 23 years old, and right-handedness.
- In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I).
- Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score> 13 at screening.
- Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
Who cannot join
- A diagnosis of other psychiatric disorders in the DSM-5.
- Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study.
- History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma.
- Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening.
- History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders.
- There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.
- Participation in any investigational drug trial within 6 months before the baseline visit.
- Other conditions that are not suitable for the study object in the researcher's judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Deep Transcranial Magnetic Stimulation
Taiyuan, Shanxi, 030001
Zhifen Liu, 86+13703586547, zhifenliu@sxmu.edu.cn
- Recruiting
Deep Transcranial Magnetic Stimulation
Taiyuan, Shanxi, 030012
zhifen ZF Liu, +8613703586547, zhifenliu@sxmu.edu.cn
About this study
Official title: Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial
The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil.
The main questions it aims to answer are:
Type of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.
Read the detailed description
Transcranial magnetic stimulation (TMS) is a safe and well-tolerated intervention that has been extensively studied as a treatment for MDD. However, little is known about the effectiveness of deep transcranial magnetic stimulation (dTMS) in adolescents with major depressive disorder (MDD). Only one open-label trial tested dTMS using H1 coils in adolescents with treatment-resistant depression, the results showed that the severity of depressive symptoms was significantly reduced after treatment, with a response rate of 42%. Hence, the continued efforts are needed to improve and optimize these treatments.
One important factor that influence the efficacy of TMS was the seletion of stimulation target. In recent years, medial prefrontal cortex (MPFC) and anterior cingulate cortex (ACC) have recently been considered promising alternative targets for treatment of adolescents with MDD, due to their association with reward, emotion, mood, and habits. Additionally, the stimulation target for dTMS with the H7 coil is the MPFC. Current relevant clinical studies show that after dTMS intervention using the H7 coil, depressive symptoms and overall clinical impressions in adults with MDD are significantly improved. However, whether alternative strategies for TMS treatment (e.g., H1 coil versus H7 coil) are more effective in adolescents with MDD remains unknown.
The purpose of this randomized controlled trial is to evaluate the efficacy and safety of two different dTMS devices (H1 coil and H7 coil) in the treatment of adolescent with MDD, further providing clinicians with additional treatment options for patients.
- Conditions
- Major Depressive Diorder
- Being tested
- deep transcranial magnetic stimulation with H1coil, deep transcranial magnetic stimulation with H7 coil
- Keywords
- deep transcranial magnetic stimulation, Major Depressive Diorder, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep transcranial magnetic stimulation with H1coilDevice
Participants will receive dTMS treatment with H1 coil
deep transcranial magnetic stimulation with H7 coilDevice
Participants will receive dTMS treatment with H7 coil
| Study group | Role | What they receive |
|---|---|---|
| H1 coil | Active comparator | First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H1 coil was advanced 6 cm anterior to the scalp surface.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over the left dorsolateral prefrontal cortex. Receives: Device: deep transcranial magnetic stimulation with H1coil |
| H7 coil | Experimental | First, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H7 coil was advanced 4 cm anterior to 'hot spot' and aligned symmetrically over the dmPFC. The rMT was rechecked at least once a week.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over themedial prefrontal cortex. Receives: Device: deep transcranial magnetic stimulation with H7 coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale -24 (HAMD-24)
score change. Higher score means worse outcome.(Min = 0, Max = 76)
Measured: From enrollment to the end of treatment at 12 weeks
Response on Hamilton Depression Scale-24
Defined as a score reduction of 50% or more
Measured: From enrollment to the end of treatment at 12 weeks
Remission onHamilton Depression Scale-24
Defined as a score of 7 or less
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
Hamilton Anxiety Rating Scale (HAM-A)
score change. Higher score means worse outcome.(Min = 0, Max = 56)
Measured: From enrollment to the end of treatment at 12 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
score change. Higher score means worse outcome.(Min= 0, Max = 56)
Measured: From enrollment to the end of treatment at 12 weeks
Beck Scale for Suicide Ideation-Chinese Version (BSI-CV)
score change. Higher score means worse outcome.(Min= 0, Max = 38)
Measured: From enrollment to the end of treatment at 12 weeks
Self-Injury Diary Card
Higher numeric value means worse outcome.
Measured: From enrollment to the end of treatment at 12 weeks
Pittsburgh sleep quality index(PSQI)
Higher score means worse outcome.(Min= 0, Max = 21)
Measured: From enrollment to the end of treatment at 12 weeks
Clinical Global Impression (CGI)
Higher score means worse outcome.(Min= 0, Max = 7)
Measured: From enrollment to the end of treatment at 12 weeks
Repeatable Battery for the Assessmental of Neuropsychological Status(RBANS)
Lower score means worse outcome.(Min=40, Max = 160)
Measured: From enrollment to the end of treatment at 12 weeks
Brief Symptom Inventory-18(BSI-18)
Higher score means worse outcome.(Min= 0, Max = 90)
Measured: From enrollment to the end of treatment at 12 weeks
Beck Depression Inventory-II
score change. Higher score means worse outcome.(Min= 0, Max = 63)
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start31 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DiorderStudies 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
- Model description
- randomized, double-blind,single-center, two-arm, parallel-group superiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhifen Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhifen Liu, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728280
- Sponsor's protocol ID
- NO.KYLL-2024-001
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06728280
- Acronym / sponsor ID
- NO.KYLL-2024-001
- Conditions
- Major Depressive Diorder
- Keywords
- deep transcranial magnetic stimulation, Major Depressive Diorder, adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhifen LiuUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Dec 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.
The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil.
The main questions it aims to answer are:
Type of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.
Detailed description
Transcranial magnetic stimulation (TMS) is a safe and well-tolerated intervention that has been extensively studied as a treatment for MDD. However, little is known about the effectiveness of deep transcranial magnetic stimulation (dTMS) in adolescents with major depressive disorder (MDD). Only one open-label trial tested dTMS using H1 coils in adolescents with treatment-resistant depression, the results showed that the severity of depressive symptoms was significantly reduced after treatment, with a response rate of 42%. Hence, the continued efforts are needed to improve and optimize these treatments.
One important factor that influence the efficacy of TMS was the seletion of stimulation target. In recent years, medial prefrontal cortex (MPFC) and anterior cingulate cortex (ACC) have recently been considered promising alternative targets for treatment of adolescents with MDD, due to their association with reward, emotion, mood, and habits. Additionally, the stimulation target for dTMS with the H7 coil is the MPFC. Current relevant clinical studies show that after dTMS intervention using the H7 coil, depressive symptoms and overall clinical impressions in adults with MDD are significantly improved. However, whether alternative strategies for TMS treatment (e.g., H1 coil versus H7 coil) are more effective in adolescents with MDD remains unknown.
The purpose of this randomized controlled trial is to evaluate the efficacy and safety of two different dTMS devices (H1 coil and H7 coil) in the treatment of adolescent with MDD, further providing clinicians with additional treatment options for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind,single-center, two-arm, parallel-group superiority trial
| Arm | Type | Receives |
|---|---|---|
| H1 coil | Active comparator | Device: deep transcranial magnetic stimulation with H1coilFirst, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H1 coil was advanced 6 cm anterior to the scalp surface.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over the left dorsolateral prefrontal cortex. |
| H7 coil | Experimental | Device: deep transcranial magnetic stimulation with H7 coilFirst, the 'hot spot' for activation of the abductor pollicis brevis muscle was established and motor threshold (MT) determined. Then, the H7 coil was advanced 4 cm anterior to 'hot spot' and aligned symmetrically over the dmPFC. The rMT was rechecked at least once a week.The rMT was rechecked at least once a week. Treatment intensity was 80% of rMT.During 4 consecutive weeks (5 sessions/wk) patients were treated daily . Patients in the treatment group will receive the Deep TMS protocol (80% of rMT, 18 Hz, 2 seconds on and 20 seconds off over a 20-minute period; total of 1,980 stimuli per session), applied over themedial prefrontal cortex. |
Who may qualify
- Ages
- 11 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients of all genders, aged between 11 and 23 years old, and right-handedness.
- In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I).
- Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score> 13 at screening.
- Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
Key exclusion criteria (8 listed)
- A diagnosis of other psychiatric disorders in the DSM-5.
- Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study.
- History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure/epilepsy disorder, or history of significant head trauma.
- Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening.
- History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders.
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 |
|---|---|---|
| deep transcranial magnetic stimulation with H1coilParticipants will receive dTMS treatment with H1 coil | Device | H1 coil |
| deep transcranial magnetic stimulation with H7 coilParticipants will receive dTMS treatment with H7 coil | Device | H7 coil |
Primary outcome
Hamilton Depression Scale -24 (HAMD-24)
Time frame: From enrollment to the end of treatment at 12 weeks
score change. Higher score means worse outcome.(Min = 0, Max = 76)
Response on Hamilton Depression Scale-24
Time frame: From enrollment to the end of treatment at 12 weeks
Defined as a score reduction of 50% or more
Remission onHamilton Depression Scale-24
Time frame: From enrollment to the end of treatment at 12 weeks
Defined as a score of 7 or less
9 secondary outcomes
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: From enrollment to the end of treatment at 12 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: From enrollment to the end of treatment at 12 weeks
Beck Scale for Suicide Ideation-Chinese Version (BSI-CV)
Time frame: From enrollment to the end of treatment at 12 weeks
Self-Injury Diary Card
Time frame: From enrollment to the end of treatment at 12 weeks
Pittsburgh sleep quality index(PSQI)
Time frame: From enrollment to the end of treatment at 12 weeks
Clinical Global Impression (CGI)
Time frame: From enrollment to the end of treatment at 12 weeks
Repeatable Battery for the Assessmental of Neuropsychological Status(RBANS)
Time frame: From enrollment to the end of treatment at 12 weeks
Brief Symptom Inventory-18(BSI-18)
Time frame: From enrollment to the end of treatment at 12 weeks
Beck Depression Inventory-II
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep transcranial magnetic stimulation with H1coil and deep transcranial magnetic stimulation with H7 coil in people with Major Depressive Diorder, run by Zhifen Liu at 2 sites in China.
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 5 inclusion and 8 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Zhifen Liu (+8613703586547, zhifenliu@sxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale -24 (HAMD-24) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.