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Personalized Brain Functional Sectors (pBFS) based Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder: A Multisite, Randomized, Placebo-Controlled Trial

Personalized Brain Functional Sectors (pBFS) based Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder: A Multisite, Randomized, Placebo-Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067671
Enrollment
Unknown
Registered
2023-01-17
Start date
2023-05-20
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Depression

Interventions

Active -rTMS group:stable antidepressant regimen and rTMS
Sham -rTM group:stable antidepressant regimen and pseudo rTMS

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. DSM-5 diagnosis of depressive disorder, single or recurrent episodes; 2. A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale; 3. Aged 18-65 years, female or male; 4. Inadequate response to at least one antidepressant trial of adequate doses and duration; 5. The MSM (Maudsley Staging Method) score >= 7; 6. Stable antidepressant regimen for at least 4 weeks before treatment; 7. Educated for at least 5 years; 8. Understand the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. A lifetime psychiatric history of psychotic disorders, bipolar I or II disorders, obsessive-compulsive disorder, secondary depression, etc; 2. Implanted electronic devices (e.g. pacemakers, cochlear implants) or other metallic implants; or contraindications to MRI or contraindications to rTMS treatment; 3. History of seizure disorder (at least 2 unprovoked seizures separated by more than 24 hours, or diagnosis of epilepsy syndrome, or seizures within the past 12 months); 4. Prior treatment with electroconvulsive therapy (ECT), rTMS, or light therapy within 3 months; 5. Systemic brain disease (e.g. ischemic stroke, brain tumor) or traumatic brain injury); 6. Severe heart, liver, kidney disease, diabetes, and other serious physical diseases, etc. 7. Women who were pregnant, breastfeeding, and intend or may become pregnant during the trial; 8. Drug and alcohol abuse within the past year; 9. First-degree relative with bipolar disorder; 10. Serious suicidal ideation/behavior (e.g. item 10 of MADRS >= 5 points); 11. Difficult to communicate or understand or follow instructions, and be unable to cooperate with the treatment and assessment; 12. Currently participant in clinical trials of other drugs or physical therapy (e.g deep brain stimulation, ECT, rTMS); 13. Investigators think that was inappropriate to participate.

Design outcomes

Secondary

MeasureTime frame
Hamilton Depression Scale (HAMD);Hamilton Anxiety Rating Scale (HAMA);Clinical Global Impression Scale-Severity (CGI-S);Global Assessment of Functioning (GAF);Frequency, Intensity, Burden of Side Effects Rating (FIBSER);

Primary

MeasureTime frame
Montgomery-Asberg Depression Rating Scale (MADRS);

Countries

China

Contacts

Public ContactWang Gang

Beijing Anding Hospital Capital Medical University

qinqin1818@yeah.net+86 139 1169 5727

Outcome results

None listed

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