The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression

Zhejiang University

Status: Enrolling

Conditions: Treatment-resistant Depression

Treatments: Device: active iTBS; Device: sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05607654

82271562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

active iTBS

Active Comparator group

Description:

The active group of TRD will receive the accelerated intermittent TBS(iTBS).The iTBS cycles including 10 bursts of three pulses at 50 Hz were delivered in 2-second trains. Each iTBS session comprised 60 x 2 second trains, with an 8-second intertrain interval and total duration of 10-minutes.Treatment sessions were administered hourly 10 times a day totaling 18,000 pulses/day. Patients received this treatment protocol for 5 consecutive days (90,000 pulses in total).

Treatment:

Device: active iTBS

sham rTMS

Sham Comparator group

Description:

The sham group of TRD will receive sham rTMS stimulation.

Treatment:

Device: sham rTMS