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Functional MRI–Guided Individualized TMS for Precision Treatment of Depression and Its Neuroimaging Mechanisms: A Prospective, Multicenter, Randomized, Double-Blind Controlled Clinical Trial

Functional MRI–Guided Individualized TMS for Precision Treatment of Depression and Its Neuroimaging Mechanisms: A Prospective, Multicenter, Randomized, Double-Blind Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126167
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression disorder

Interventions

Control group:Classical 5-cm targeting stimulation
Experimental group:FC-guided individualized targeting stimulaiton

Sponsors

Affiliated Hospital of Hangzhou Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meets the clinical diagnostic criteria for depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 2.First visit to the hospital after symptom onset and either: Has not yet received antidepressant treatment or has been treated for no more than 2 weeks (acute phase), or Is receiving a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI) (maintenance phase), or Has shown inadequate response to standard antidepressant treatment (treatment-resistant depression); 3.Outpatient or inpatient; 4.Aged 18–65 years; 5.Hamilton Depression Rating Scale (HAMD-17) score > 17; 6.Provides written informed consent after fully understanding the study procedures.

Exclusion criteria

Exclusion criteria: 1.Presence of implanted metallic or electronic devices, such as cardiac pacemakers, nerve stimulators, metallic prosthetic heart valves, intraocular metallic foreign bodies, cochlear implants, metallic prostheses (e.g., artificial joints), or other ferromagnetic foreign bodies in the body; 2.History of brain disorders or other serious medical conditions; 3.Any contraindication to brain MRI (participants must complete an MRI safety screening form when providing informed consent); 4.Pregnant, breastfeeding, or planning pregnancy during the study period; 5.Acute suicidal behavior requiring emergency intervention within the past week; 6.Presence of psychotic symptoms requiring concomitant antipsychotic medication; 7.History of neuroleptic malignant syndrome or severe tardive dyskinesia; 8.Inability to adhere to prescribed medication regimens.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (17-item version) (HAMD-17) Score;

Secondary

MeasureTime frame
Beck Scale for Suicide Ideation-Chinese Version (BSI-CV);Montgomery-Asberg Depression Rating Scale (MADRS);Resting-state fMRI metrics;Adverse effects;Hamilton Anxiety Scale (HAMA) Score;

Countries

China

Contacts

Public ContactZhu Chunying

Affiliated Hospital of Hangzhou Normal University

zcypsy@163.com+86 571 88303660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026