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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized transcranial magnetic stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial magnetic stimulation | Device | Individualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula . |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and treatment day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yaochi Zhang | Contact | 18294037117 | a18294037117@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huaning Wang | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35026139 | Background | 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. | |
| 28886760 | Background |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Baseline and 28 days after the end of treatment |
| Philip 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. |
| 32800379 | Background | Cash 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. |
| 34482948 | Background | Goldstein-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. |