Clinical trial NCT06837207: Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry
Official title: Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Transcranial Magnetic Stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
timeFrame: Baseline and treatment day 10
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Hamilton Anxiety Scale scores from baseline to treatment day 10
timeFrame: Baseline and treatment day 10
measure: Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10
timeFrame: Baseline and treatment day 10
measure: Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10
timeFrame: Baseline and treatment day 10
measure: Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
measure: Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10
timeFrame: Baseline and treatment day 10
measure: Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment
timeFrame: Baseline and 28 days after the end of treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Huaning Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.