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

Treatment-resistant Depression Clinical Trial

Official title:

The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607654
• Other study ID #: 82271562
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Manli Huang, M.D
• Phone: 13957162975
• Email: huangmanli[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment-resistant Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.	The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4.; Remission is defined as HAM-D24 =8.	Baseline, 5-day, 1-month
Secondary	Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.	The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4.; Response is defined as a reduction of >/=50% of HAM-D24 baseline score.	Baseline, 5-day, 1-month
Secondary	Change in the rate of Beck Scale of Suicidal Ideation score after treatment.	Beck Scale of Suicidal Ideation(BSI) is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week.	Baseline, 5-day, 1-month
Secondary	Change in the rate of Hamilton Anxiety Scale score after treatment.	Hamilton Anxiety Scale (HAMA) is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients	Baseline, 5-day, 1-month