Actively Recruiting

Phase Not Applicable
Age: 12Years - 45Years
All Genders
Healthy Volunteers
NCT05913960

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2023-06-22

90

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent to participate and receive treatment
  • Diagnosed with major depressive disorder
  • Hamilton Depression Scale (HAMD-24) total score of 20 or more
  • First episode or recurrent depression patients not currently taking psychiatric drugs
  • Han nationality and right-handed
  • Education level of junior high school or above
Not Eligible

You will not qualify if you...

  • Other organic mental disorders, mental retardation, or severe mental disorders
  • Infection, trauma, autoimmune diseases, or other conditions that may affect test evaluations
  • Alcohol or drug dependence or current treatment with hormone drugs
  • History of craniocerebral injury
  • Seizure history or family history of epilepsy
  • Pregnant or lactating women
  • Presence of metal in the body, MRI contraindications, or abnormal brain structure on MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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