Clinical trial NCT05607654: The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
Official title: The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment-resistant Depression
Keywords: Treatment-resistant Depression
Repeated transcranial magnetic stimulation
Prefrontal-hippocampal circuit
Reelin
Synaptic plasticity
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
2. 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
3. Age 18-45 years, regardless of gender.
4. Right-handedness.
5. Han Chinese.
6. Signed a written informed consent, willing to participate in the study and be evaluated.

Exclusion Criteria:

1. Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
2. Patients with metal objects in the body or with other contraindications to MRI scanning
3. Patients with severe or unstable somatic diseases
4. Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
5. Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.

Primary outcomes:
measure: Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
timeFrame: Baseline, 5-day, 1-month
Secondary outcomes:
measure: Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
timeFrame: Baseline, 5-day, 1-month
measure: Change in the rate of Beck Scale of Suicidal Ideation score after treatment.
timeFrame: Baseline, 5-day, 1-month
measure: Change in the rate of Hamilton Anxiety Scale score after treatment.
timeFrame: Baseline, 5-day, 1-month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: