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Intensive Accelerated iTBS for the Treatment-Resistant Depression

NCT06166082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-11

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.

Conditions

Interventions

DEVICE

Active iTBS-DLPFC

Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.

DEVICE

Sham iTBS-DLPFC

The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.

Sponsors & Collaborators

  • Xianyue Hospital, Xiamen

    collaborator UNKNOWN

  • Hebei Mental Health Center, Baoding

    collaborator UNKNOWN

  • HuiLongGuan Hospital, Beijing

    collaborator UNKNOWN

  • Wuhan Mental Health Centre

    collaborator OTHER

  • Zhumadian Second People's Hospital, Zhumadian

    collaborator UNKNOWN

  • Changping Laboratory

    lead OTHER

Principal Investigators

  • Hesheng Liu, Ph.D. · Changping Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2025-03-21
Completion
2025-04-21

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166082 on ClinicalTrials.gov