Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder, Major Depressive Disorder, Recurrent

In brief

Major depressive disorder(MDD) is a complex and heterogeneous mental disorder. Repeated transcranial magnetic stimulation (rTMS), as a non-invasive neuroregulatory technique, has shown a promising function in the treatment of depression. Theta-burst transcranial magnetic stimulation (TBS) model significantly shortened the duration of physical therapy treatment, and iTBS under the accelerated model (The latter is referred to as aiTBS)showed promising therapeutic effect. However, whether aiTBS has a better and faster curative effect in the first untreated or recurrent unmedicated MDD patients and the mechanism of its alleviation of depressive symptoms remains unclarified. This project intends to verify changes in CAMKII levels, CAMKII molecules and GABA receptors in brain-derived exosomes in normal controls and patients who received sham, aiTBS and high-frequency (10Hz) stimulation respectively. Neuroimaging and TMS-EEG were used to pinpoint the target of stimulation and to record the changes of brain waves before and after treatment in real time. To clarify the neurobiological mechanism of aiTBS rapidly improving depression, and to provide a new strong evidence for clinical transcranial magnetic stimulation for accurate treatment of MDD patients.

Key facts

Study ID

NCT05913960

Run by

First Affiliated Hospital of Zhejiang University

People needed

90

Starts

2023-02-09

Expected to finish

2027-03-15

Last updated by the study team

2023-06-22

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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