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The study of neuronavigation-guided transcranial magnetic stimulation of the orbitofrontal cortex for rapid antidepressant efficacy and safety

The study of neuronavigation-guided transcranial magnetic stimulation of the orbitofrontal cortex for rapid antidepressant efficacy and safety

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058289
Enrollment
Unknown
Registered
2022-04-04
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Depression

Interventions

Experimental group:Drug combined transcranial magnetic stimulation(TMS)
Control group:Drug combined with TMS sham stimulation

Sponsors

The First Affiliated Hospital of the Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, right-handed; 2. Meet the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. Total score of HAMD-17 >17; 4. No clinically significant abnormalities in EEG; 5. After fully understanding TMS treatment, be willing to actively cooperate with the treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a history of serious physical diseases or diseases that may affect the central nervous system (tumor, syphilis, etc.); 2. Have neurological diseases or risk of seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of brain structural abnormalities, or a family history of epilepsy; 3. Patients with bipolar disorder and depression caused by other mental illnesses (such as psychoactive substances and non-dependent substances); 4. MRI scanning or transcranial magnetic stimulation for treatment of contraindications, such as metal or electronic instruments in the body (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents and other metal foreign bodies); 5. Patients with psychotic symptoms requiring combined use of antipsychotic drugs; 6. Patients at high risk of suicide, or those who have committed suicide or serious self-injury and need emergency intervention; 7. Received any form of antidepressant therapy within 1 month before enrollment; 8. Pregnant, breastfeeding or planning pregnancy during the trial; 9. Other conditions that the researcher has judged unsuitable for the study.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD-17);

Secondary

MeasureTime frame
Subtraction value and effective rate of HAMD-17;Reduction value and effectiveness of Montgomery Depression Scale;Beck Suicidal Ideation Scale;Cognitive function;Brain imaging changes;

Countries

China

Contacts

Public ContactWang Hua'ning
xskzhu@fmmu.edu.cn+86 13609161341

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026