Identifying and treating treatment-resistant depression early with new technology
Early Identification of Treatment-resistant Depression and Construction and Clinical Validation of Non-invasive Transcranial Deep Brain Stimulation Precision Technology
This study is testing a new way to find and treat people with treatment-resistant depression early by using advanced technology that looks at their symptoms, blood, and brain activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05777876 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve the early identification and treatment of treatment-resistant depression (TRD) by developing a multimodal identification model that incorporates clinical characteristics, blood factors, and brain imaging indicators. The study will utilize non-invasive transcranial deep brain stimulation technology tailored to individual patients based on precise magnetic resonance targets and EEG phase guidance. Participants will undergo multiple assessments to gather data on clinical symptoms and biological markers, which will help in constructing a more effective intervention strategy for TRD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 with a diagnosis of major depression who have not responded to at least two full-dose antidepressant treatments.
Not a fit: Patients with comorbid mental disorders, serious physical diseases, or contraindications for MRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more effective treatments for patients suffering from treatment-resistant depression.
How similar studies have performed: While the approach of using non-invasive brain stimulation is established, the specific combination of early identification and precision technology in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * This episode meets the diagnostic criteria of DSM-5 major depression, and is not accompanied by psychotic symptoms in the first episode or relapse of unmedicated depression; * 24 item Hamilton Depression Scale (HAMD-24)≥20; * Age 18-60, gender unlimited; * right hand; * Han Chinese; * Sign a written informed consent and be willing to participate in the study and be evaluated. Exclusion Criteria: * Comorbidities with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc. * Patients with metal objects in the body or other contraindications for MRI scanning; * Suffering from a serious or unstable physical disease; * Positive urine HCG test results of pregnant and lactating women and women of childbearing age during screening; * Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Manli Huang, Professor — Zhejiang University
- Study coordinator: Manli Huang, Professor
- Email: huangmanli@zju.edu.cn
- Phone: 13957162975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.