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

Primary Purpose

Treatment-resistant Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active iTBS
sham rTMS
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Treatment-resistant Depression focused on measuring Treatment-resistant Depression, Repeated transcranial magnetic stimulation, Prefrontal-hippocampal circuit, Reelin, Synaptic plasticity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active iTBS

sham rTMS

Arm 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).

The sham group of TRD will receive sham rTMS stimulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
October 26, 2022
Last Updated
January 12, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05607654
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-resistant Depression
Keywords
Treatment-resistant Depression, Repeated transcranial magnetic stimulation, Prefrontal-hippocampal circuit, Reelin, Synaptic plasticity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active iTBS
Arm Type
Active Comparator
Arm 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).
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
The sham group of TRD will receive sham rTMS stimulation.
Intervention Type
Device
Intervention Name(s)
active iTBS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
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 Outcome Measure Information:
Title
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Description
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.
Time Frame
Baseline, 5-day, 1-month
Secondary Outcome Measure Information:
Title
Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Description
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.
Time Frame
Baseline, 5-day, 1-month
Title
Change in the rate of Beck Scale of Suicidal Ideation score after treatment.
Description
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.
Time Frame
Baseline, 5-day, 1-month
Title
Change in the rate of Hamilton Anxiety Scale score after treatment.
Description
Hamilton Anxiety Scale (HAMA) is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients
Time Frame
Baseline, 5-day, 1-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manli Huang, M.D
Phone
13957162975
Ext
86
Email
huangmanli@zju.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manli Huang, M.D
Phone
13957162975
Ext
86
Email
huangmanli@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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