Using accelerated theta-burst stimulation to treat major depressive disorder
Official title: the Mechanism of Accelerated Intermittent Theta Burst Stimulation for Rapid Treatment of Major Depressive Disorder Based on the Prefrontal Excitation-inhibition Balance Regulated by CAMKII Pathway
Run by First Affiliated Hospital of Zhejiang University · NCT05913960 · Data updated 2026-11-12
This study is testing if a new brain stimulation technique can help people with major depression feel better faster than usual treatments, especially for those who haven't taken medication yet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 45 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 9, 2023 |
| Main results expected | March 15, 2024 |
| Study ends | March 15, 2027 |
| Registry record updated | June 22, 2023 |
| Trial ID | NCT05913960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include right-handed individuals of Han nationality diagnosed with major depressive disorder who are experiencing their first episode or recurrent depression and are not currently on psychiatric medication.
✕Probably not a fit
Patients with other severe mental disorders, a history of seizures, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of accelerated intermittent theta-burst stimulation (aiTBS) on patients with major depressive disorder (MDD), particularly those experiencing their first episode or recurrent depression without medication. The research aims to determine whether aiTBS can provide a faster and more effective treatment compared to traditional methods. It will analyze changes in specific brain molecules and receptors in response to different stimulation techniques, including sham stimulation and high-frequency stimulation. Neuroimaging and TMS-EEG will be utilized to identify the stimulation targets and monitor brain activity during treatment.
Why it matters
Potential benefit: If successful, this approach could offer a rapid and effective treatment option for patients suffering from major depressive disorder.
How similar studies have gone: Previous studies have shown promising results with transcranial magnetic stimulation techniques, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sign a written informed consent to participate in the trial and receive treatment; * Major depressive disorder diagnosis; * Hamilton depression scale (HAMD - 24) 24 total score 20 points or more; * First episode or recurrence of depression patients, not taking psychiatric drugs; * The han nationality, right-handed; * Junior high school or above; Exclusion Criteria: * Other organic mental disorders and mental retardation and other severe mental disorders; * Infection, trauma, and autoimmune diseases or other possible interference test evaluation of disease; * Alcohol and drug dependence or is being treated for a hormone drugs patients; * Craniocerebral injury; * Seizure or a family history of epilepsy; * Pregnancy and lactation women; * All landowners had a metal and MRI contraindications or MRI examination revealed abnormal brain structure.
Where it's running
-
the First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Dupilumab for Major Depressive Disorder
This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.
-
Accelerated vs Standard iTBS for Major Depression
This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.
-
Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD
This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.
-
Magnesium Bisglycinate Added to Your Depression Treatment
This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.
-
Motif XCS System for treatment-resistant depression
This study tests whether the Motif XCS System is safe and tolerable and might help people with treatment-resistant major depressive disorder.
-
A Phase 3 test of DT120 for major depressive disorder
DT120 is tested against placebo in adults with major depressive disorder to see if it can help reduce depressive symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.