Accelerated rTMS for treatment-resistant depression
The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
This study is testing a faster way of using brain stimulation to see if it can help people with depression who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05607654 on ClinicalTrials.gov |
What this trial studies
This project evaluates an accelerated schedule of repetitive transcranial magnetic stimulation (rTMS) for individuals suffering from treatment-resistant depression. Participants are divided into two groups, receiving either active stimulation or a sham treatment, while their brain activity and blood markers are monitored. The study aims to understand the mechanisms behind accelerated rTMS by assessing neuroimaging and biomarker changes at baseline, five days post-treatment, and one month later.
Who should consider this trial
Good fit: Ideal candidates are Han Chinese individuals aged 18-45 with a diagnosis of major depression who are unmedicated and right-handed.
Not a fit: Patients with co-morbid mental disorders, severe somatic diseases, or contraindications to MRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with treatment-resistant depression.
How similar studies have performed: While the approach of accelerated rTMS is relatively novel, similar studies have shown promise in improving outcomes for treatment-resistant depression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms. 2. 24-item Hamilton Depression Scale (HAMD-24) ≥ 20. 3. Age 18-45 years, regardless of gender. 4. Right-handedness. 5. Han Chinese. 6. Signed a written informed consent, willing to participate in the study and be evaluated. Exclusion Criteria: 1. Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc. 2. Patients with metal objects in the body or with other contraindications to MRI scanning 3. Patients with severe or unstable somatic diseases 4. Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period 5. Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Manli Huang, M.D
- 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.