Actively Recruiting
The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway-Mediated Synaptic Plasticity
Led by First Affiliated Hospital of Zhejiang University · Updated on 2023-01-13
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an accelerated schedule of repetitive transcranial magnetic stimulation (rTMS) for people with treatment-resistant depression. The study aims to better understand how this accelerated rTMS works by examining brain activity and specific blood markers such as Reelin, Apoer2, NMDAR, BDNF, and exosomes. Participants include adults aged 18 to 45 years who meet criteria for major depression without psychotic symptoms. Participants are randomly assigned to two groups: one receives active accelerated intermittent theta burst stimulation (iTBS) to the left dorsolateral prefrontal cortex using a neuronavigation system, and the other receives a sham (placebo) rTMS treatment. The active group undergoes ten 10-minute sessions per day for five consecutive days, delivering a total of 90,000 pulses. The sham group receives similar procedures but with the device set to a non-active mode. During the study, researchers assess changes in depression severity using the Hamilton Depression Scale (24-items) at baseline, 5 days after treatment, and 1 month later. Additional evaluations include measures of suicidal ideation and anxiety symptoms. Brain imaging and blood biomarker tests are also performed at these time points to monitor brain activity and biological changes. Participants provide informed consent and are carefully monitored throughout the trial, which lasts about one month for outcome assessment.
CONDITIONS
Brief Title
The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The current episode meets DSM-5 criteria for major depression without psychotic symptoms
- Hamilton Depression Scale (24-items) score of 20 or higher
- Age between 18 and 45 years, any gender
- Right-handed
- Han Chinese ethnicity
- Signed informed consent and willingness to participate and be evaluated
You will not qualify if you...
- Other mental disorders such as schizophrenia, intellectual disability, or substance dependence
- Presence of metal objects in the body or contraindications to MRI scanning
- Severe or unstable physical health conditions
- Women who are pregnant, breastfeeding, or have positive pregnancy test during screening
- Any other condition judged by the investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive either accelerated intermittent theta burst stimulation (iTBS) or a sham device treatment to the left dorsolateral prefrontal cortex over 5 consecutive days.
Daily visits for 5 days
Duration - 1 month after treatment
Participants are evaluated for changes in brain activity and blood biomarkers at baseline, 5 days after treatment, and 1 month after treatment to understand the mechanisms of accelerated rTMS.
3 visits (baseline, 5 days post-treatment, 1 month post-treatment)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Manli Huang, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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