Using accelerated theta-burst stimulation to treat major depressive disorder

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 12 Years to 45 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05913960 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Previous studies have shown promising results with transcranial magnetic stimulation techniques, suggesting potential success for this novel approach.

Eligibility 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 this trial is running

Hangzhou, Zhejiang

• the First Affiliated Hospital,Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Conditions Major Depressive Disorder; Major Depressive Disorder, Recurrent; major depressive disoerder; first episode without medication; recurrent unmedicated