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Recruiting NCT05913960

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

No phase Interventional Major Depressive Disorder Major Depressive Disorder, Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sham stimulation, accelerated intermittent theta burst stimulation, high frequency stimulation.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Major Depressive Disorder, Recurrent. Basic parameters: 12 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device sham stimulation
    The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
  • Device accelerated intermittent theta burst stimulation
    Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.
  • Device high frequency stimulation
    Participants in the active stimulation group will receive the high frequnency stimulation to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.

Primary outcome measures

  • Hamilton depression scale-24 [Time frame: baseline]
  • Hamilton depression scale-24 [Time frame: 5days]
  • Hamilton depression scale-24 [Time frame: 4 weeks]
Secondary outcome measures (12)
  • Change in the score of THINC-it. [Time frame: Baseline]
  • Change in the score of THINC-it. [Time frame: 5 days]
  • Change in the score of THINC-it. [Time frame: 4 weeks]
  • Change in neuroimaging using functional magnetic resonance [Time frame: Baseline]
  • Change in neuroimaging using functional magnetic resonance [Time frame: 5 days]
  • Change of blood factor levels [Time frame: baseline]
  • Change of blood factor levels [Time frame: 5 days]
  • Change of blood factor levels [Time frame: 4 weeks]
  • Change in electroencephalogram [Time frame: baseline]
  • Change in electroencephalogram [Time frame: 5 days]
  • Hamilton anxiety scale [Time frame: baseline]
  • Hamilton anxiety scale [Time frame: 5 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital,Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT05913960 · IITA20230315

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗