pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Depression

NCT05842291 | Suspended

• 1 other identifier: CPLMDDhlg2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to evaluate the safety and efficacy of pBFS-guided high-dose rTMS therapy with short inter-session interval for patients with treatment-resistant depression

Conditions

Treatment-Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 4 weeks post-treatment

  The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher scores represent higher depression severity. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).

  Baseline, 28 days post-treatment

Secondary Outcomes (3)

• Change in MADRS, HAMD-17, and QIDS_SR from baseline to different time points

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment

• Remission and response rates estimated using MADRS, HAMD, QIDS_SR

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment

• Safety measures using SSI and YMRS

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment

Study Arms (3)

Active rTMS with short inter-session interval

EXPERIMENTAL

Patients in this group will receive rTMS intervention with short inter-session intervals.

Device: Active rTMS with short inter-session interval

Sham rTMS with short inter-session interval

SHAM COMPARATOR

Patients in this group will receive sham rTMS intervention with short inter-session intervals.

Device: Sham rTMS with short inter-session interval

Active rTMS with long inter-session interval

ACTIVE COMPARATOR

Patients in this group will receive rTMS intervention with long inter-session intervals.

Device: Active rTMS with long inter-session interval

Interventions

Active rTMS with long inter-session interval DEVICE

Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 50 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.

Active rTMS with long inter-session interval

Active rTMS with short inter-session interval DEVICE

Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.

Active rTMS with short inter-session interval

Sham rTMS with short inter-session interval DEVICE

Participants in this group will receive ten sessions per day of 1800 pulses per session, at an inter-session interval of 20 min for 5 days, using sham stimulation coils that comprehensively mimic the active condition. The individualized target will be generated using the personalized Brain Functional Sectors (pBFS) method.

Sham rTMS with short inter-session interval

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
• Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing the first episode or recurrence episode.
• Total HAMD17 score ≥18 before randomization.
• Total MADRS score ≥20 before randomization.
• A stable or no-drug use for at least 4 weeks before randomization. The type and dose of the antidepressant regimen remained unchanged throughout the study.
• No response (symptom improvement≥50%) in previous treatments with at least two antidepressants for a full dose and full course.
• Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.

You may not qualify if:

• Meet DSM-5 diagnostic criteria for other mental disorders (e.g., schizophrenia spectrum disorders, bipolar and related disorders, anxiety disorders, compulsion, and related disorders, trauma and stress-related disorders, etc.), or secondary depression;
• Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
• Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
• History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
• History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
• Currently receiving or planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial.
• Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
• Female of childbearing potential who plans to become pregnant during the trial.
• Female that is pregnant or breastfeeding.
• Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
• Investigators think that was inappropriate to participate.

Sponsors & Collaborators

• Changping Laboratory: lead
• Beijing HuiLongGuan Hospital: collaborator

Study Sites (1)

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 100096, China

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hesheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (1)