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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Hamilton depression scale-24
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Hamilton depression scale-24
Time Frame: 4 weeks
Assessement of depressive status,a score of more than 35 May indicate severe depression; More than 20 points, may be mild or moderate depression; A score of less than 8 indicates no symptoms of depression
Secondary Outcomes
- Change in the score of THINC-it.(4 weeks)
- Change in neuroimaging using functional magnetic resonance(5 days)
- Change of blood factor levels(4 weeks)
- Change in electroencephalogram(5 days)
- Hamilton anxiety scale(4 weeks)