Clinical trial NCT05913960: Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Major Depressive Disorder, Recurrent
Keywords: major depressive disoerder
first episode without medication
recurrent unmedicated
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Hamilton depression scale-24
timeFrame: baseline
measure: Hamilton depression scale-24
timeFrame: 5days
measure: Hamilton depression scale-24
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in the score of THINC-it.
timeFrame: Baseline
measure: Change in the score of THINC-it.
timeFrame: 5 days
measure: Change in the score of THINC-it.
timeFrame: 4 weeks
measure: Change in neuroimaging using functional magnetic resonance
timeFrame: Baseline
measure: Change in neuroimaging using functional magnetic resonance
timeFrame: 5 days
measure: Change of blood factor levels
timeFrame: baseline
measure: Change of blood factor levels
timeFrame: 5 days
measure: Change of blood factor levels
timeFrame: 4 weeks
measure: Change in electroencephalogram
timeFrame: baseline
measure: Change in electroencephalogram
timeFrame: 5 days
measure: Hamilton anxiety scale
timeFrame: baseline
measure: Hamilton anxiety scale
timeFrame: 5 days
measure: Hamilton anxiety scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: