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NCT Number: NCT05607654

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

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.

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Key information

Conditions

Treatment-resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Manli Huang, M.D

CONTACT

[email protected]

13957162975 ext. 86

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active iTBS

Device

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

Device

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 outcomes

  1. Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.

    Time frame: Baseline, 5-day, 1-month

    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.

Secondary outcomes

  1. Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.

    Time frame: Baseline, 5-day, 1-month

    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.

  2. Change in the rate of Beck Scale of Suicidal Ideation score after treatment.

    Time frame: Baseline, 5-day, 1-month

    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.

  3. Change in the rate of Hamilton Anxiety Scale score after treatment.

    Time frame: Baseline, 5-day, 1-month

    Hamilton Anxiety Scale (HAMA) is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients

Study contacts

Contact information is provided by the study sponsor or research team.

Manli Huang, M.D

CONTACT

[email protected]

13957162975 ext. 86

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 7, 2022
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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