pBFS-Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression

NCT05976009 | Unknown

• 1 other identifier: CPLMDDdiffTargXY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.

Conditions

Major Depressive Disorder; Treatment Resistant Depression; MDD

Keywords

MDD; Major Depressive Disorder; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• change in MADRS

  A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression

  Baseline and Day 14(immediate post-treatment)

Secondary Outcomes (6)

• change in MADRS

  Baseline, Day 7, Day 14, Day 21

• change in HAMD

  Baseline, Day 7, Day 14, Day 21

• cognitive change in Digit Symbol Substitution Test (DSST)

  Baseline, Day 21 (Immediate Post-treatment)

• cognitive change in continuous performance test (CPT）

  Baseline, Day 21 (Immediate Post-treatment)

• cognitive change in Trail-Making Test (TMT)

  Baseline, Day 21 (Immediate Post-treatment)

Study Arms (1)

active rTMS treatment

EXPERIMENTAL

2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target

Device: active rTMS stimulating

Interventions

active rTMS stimulating DEVICE

Two sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

active rTMS treatment

Eligibility Criteria

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

You may qualify if:

• Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.
• Total HAMD17 score ≥20 and total MADRS score ≥20 before randomization.
• Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
• Inadequate response to at least one antidepressant trial of adequate doses and duration.
• A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization.
• The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
• 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 (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
• 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;
• 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, and light therapy within 3 months;
• Patients with serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
• Patients 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;
• Female of childbearing potential who plans to become pregnant during the trial.
• Female that is pregnant or breastfeeding.
• Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
• First-degree relatives have bipolar affective disorder.
• There is a significant risk of suicide (MADRS item 10 ≥ 5).
• Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
• Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS).
• Investigators think that was inappropriate to participate.

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (1)

Xianyue Hospital

Xiamen, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hesheng Liu

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Meiling Li, Ph.D.

CONTACT

010-80726688; meilingli@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: August 29, 2023
• Primary Completion: August 15, 2024
• Study Completion: September 20, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-08

Locations

CN (1)