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NCT Number: NCT06837207

Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry

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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Key information

Conditions

Depression Behavior Behavioral Symptoms Transcranial Magnetic Stimulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .

Exclusion criteria

  • 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.

Treatment and study plan

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 .

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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).

  2. Change in Hamilton Anxiety Scale scores from baseline to treatment day 10

    Time frame: Baseline and 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).

  3. 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

    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).

  4. Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10

    Time frame: Baseline and 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).

  5. 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

    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).

  6. Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10

    Time frame: Baseline and 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).

  7. 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

    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).

  8. Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10

    Time frame: Baseline and 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).

  9. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

yaochi Zhang

CONTACT

[email protected]

18294037117

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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