The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
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: active iTBS, sham rTMS.
- Who it may be relevant to
- Registry conditions: Treatment-resistant Depression. Basic parameters: 18 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 Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
Overview
In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
Detailed description
In this project, the investigator evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. Patients were included in two groups and received an accelerated stimulation or sham treatment. The changes of neuroimaging and biomarkers at baseline, 5 days after treatment and 1 month after treatment are evaluated. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
Interventions
- Device active iTBS
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 sham rTMS
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.
Primary outcome measures
- Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment. [Time frame: Baseline, 5-day, 1-month]
Secondary outcome measures (3)
- Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment. [Time frame: Baseline, 5-day, 1-month]
- Change in the rate of Beck Scale of Suicidal Ideation score after treatment. [Time frame: Baseline, 5-day, 1-month]
- Change in the rate of Hamilton Anxiety Scale score after treatment. [Time frame: Baseline, 5-day, 1-month]
Eligibility criteria
Inclusion criteria
- The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
- 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
- Age 18-45 years, regardless of gender.
- Right-handedness.
- Han Chinese.
- Signed a written informed consent, willing to participate in the study and be evaluated.
Exclusion criteria
- Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
- Patients with metal objects in the body or with other contraindications to MRI scanning
- Patients with severe or unstable somatic diseases
- Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
- Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
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
- Quadruple blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- The First Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT05607654 · 82271562