NCT05607654

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

October 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 13, 2023

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

October 26, 2022

Last Update Submit

January 12, 2023

Conditions

Treatment-resistant Depression

Keywords

Treatment-resistant DepressionRepeated transcranial magnetic stimulationPrefrontal-hippocampal circuitReelinSynaptic plasticity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Baseline, 5-day, 1-month

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

    Baseline, 5-day, 1-month

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

    Baseline, 5-day, 1-month

Study Arms (2)

active iTBS

ACTIVE COMPARATOR

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).

Device: active iTBS

sham rTMS

SHAM COMPARATOR

The sham group of TRD will receive sham rTMS stimulation.

Device: sham rTMS

Interventions

active iTBSDEVICE

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.

active iTBS
sham rTMSDEVICE

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.

sham rTMS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Manli Huang, M.D

CONTACT

13957162975huangmanli@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 7, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Last Updated

January 13, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)