DepressionNCT06837207
Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry
A study testing transcranial magnetic stimulation in people with Depression and Transcranial Magnetic Stimulation, run by Xijing Hospital at 1 site in China.
Trial summary
Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Transcranial Magnetic Stimulation
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gender is not limited, age 18～60 years old;
- Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
- Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
- The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .
Who cannot join
- History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
- Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
- Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
- Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
- People with psychotic symptoms requiring joint application of antipsychotic drugs;
- Those with high risk of suicide, or those who have already committed suicide or serious self-injury behavior requiring urgent intervention;
- Those who are pregnant, breastfeeding or planning to become pregnant during the trial;
- Other conditions judged by the investigator to be unsuitable as research subjects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710000
zhao, PhD, 18792536506, zhangyc_2022@126.com
About this study
Official title: Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula
Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention
- Conditions
- Depression, Transcranial Magnetic Stimulation
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Individualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula .
| Study group | Role | What they receive |
|---|---|---|
| Individualized transcranial magnetic stimulation | Experimental | Not described Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms.
Change = (treatment day 10 Score -Baseline Score).
Measured: Baseline and treatment day 10
Secondary outcomes (9)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to treatment day 10
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Change = (treatment day 10 Score -Baseline Score).
Measured: Baseline and treatment day 10
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10
Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Change = (treatment day 10 Score -Baseline Score).
Measured: Baseline and treatment day 10
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10
The Pittsburgh Sleep Quality Index is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 10 Score -Baseline Score).
Measured: Baseline and treatment day 10
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment
The Pittsburgh Sleep Quality Index is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10
The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-report questionnaire used to assess pleasure deficits (anhedonia).The SHAPS scale consists of 14 entries asking subjects to rate their level of agreement with pleasure responses in a number of pleasurable situations on a 4-point scale. The measure taken is the subject's situation in the most recent period of time. Pleasure experience is measured in four domains: interests/recreation, social interactions, sensory experiences, and food/drink. The scale has good reliability and validity in normal as well as clinical populations. Each entry is rated on a 4-point scale, with "strongly agree, agree, disagree, and strongly disagree" scoring from 1 to 4, respectively.
Change = (treatment day 10 Score -Baseline Score).
Measured: Baseline and treatment day 10
Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment
The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-report questionnaire used to assess pleasure deficits (anhedonia).The SHAPS scale consists of 14 entries asking subjects to rate their level of agreement with pleasure responses in a number of pleasurable situations on a 4-point scale. The measure taken is the subject's situation in the most recent period of time. Pleasure experience is measured in four domains: interests/recreation, social interactions, sensory experiences, and food/drink. The scale has good reliability and validity in normal as well as clinical populations. Each entry is rated on a 4-point scale, with "strongly agree, agree, disagree, and strongly disagree" scoring from 1 to 4, respectively.
Change = (28 days after the end of treatment Score -Baseline Score).
Measured: Baseline and 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huaning Wang, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837207
- Sponsor's protocol ID
- KY20242429
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
PubMed 35026139Philip NS, Barredo J, van 't Wout-Frank M, Tyrka AR, Price LH, Carpenter LL. Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Biol Psychiatry. 2018 Feb 1;83(3):263-272. doi: 10.1016/j.biopsych.2017.07.021. Epub 2017 Aug 8.
PubMed 28886760Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7.
PubMed 32800379Goldstein-Piekarski AN, Ball TM, Samara Z, Staveland BR, Keller AS, Fleming SL, Grisanzio KA, Holt-Gosselin B, Stetz P, Ma J, Williams LM. Mapping Neural Circuit Biotypes to Symptoms and Behavioral Dimensions of Depression and Anxiety. Biol Psychiatry. 2022 Mar 15;91(6):561-571. doi: 10.1016/j.biopsych.2021.06.024. Epub 2021 Jul 11.
PubMed 34482948
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula
- ClinicalTrials.gov ID
- NCT06837207
- Acronym / sponsor ID
- KY20242429
- Conditions
- Depression, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Feb 2025 (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.
Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized transcranial magnetic stimulation | Experimental | Device: transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gender is not limited, age 18～60 years old;
- Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
- Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
- The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .
Key exclusion criteria (8 listed)
- History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
- Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
- Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
- Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
- People with psychotic symptoms requiring joint application of antipsychotic drugs;
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 |
|---|---|---|
| transcranial magnetic stimulationIndividualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula . | Device | Individualized transcranial magnetic stimulation |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
Time frame: Baseline and treatment day 10
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms. Change = (treatment day 10 Score -Baseline Score).
9 secondary outcomes
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to treatment day 10
Time frame: Baseline and treatment day 10
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10
Time frame: Baseline and treatment day 10
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10
Time frame: Baseline and treatment day 10
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10
Time frame: Baseline and treatment day 10
Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment
Time frame: Baseline and 28 days after the end of treatment
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 20 Feb 2025.
- Background: PubMed 35026139GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
- Background: PubMed 28886760Philip NS, Barredo J, van 't Wout-Frank M, Tyrka AR, Price LH, Carpenter LL. Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Biol Psychiatry. 2018 Feb 1;83(3):263-272. doi: 10.1016/j.biopsych.2017.07.021. Epub 2017 Aug 8.
- Background: PubMed 32800379Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7.
- Background: PubMed 34482948Goldstein-Piekarski AN, Ball TM, Samara Z, Staveland BR, Keller AS, Fleming SL, Grisanzio KA, Holt-Gosselin B, Stetz P, Ma J, Williams LM. Mapping Neural Circuit Biotypes to Symptoms and Behavioral Dimensions of Depression and Anxiety. Biol Psychiatry. 2022 Mar 15;91(6):561-571. doi: 10.1016/j.biopsych.2021.06.024. Epub 2021 Jul 11.
- 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.
Huaning Wang principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Depression and Transcranial Magnetic Stimulation, run by Xijing Hospital at 1 site 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 4 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: opening soon, as of the sponsor's last update on 20 Feb 2025. 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 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 yaochi Zhang (18294037117, a18294037117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10 (time frame: Baseline and treatment day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837207, which also lists 4 linked publications.
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 20 Feb 2025.