pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression

NCT ID: NCT06350396

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-06-30

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The dorsomedial prefrontal cortex (DMPFC), which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression, is highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury. Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression. Therefore, exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future, thereby enabling personalized treatment and improving clinical treatment efficacy.

After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized double-blind in a 1:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a 3-week, 9-week, and 6-month post-treatment follow-up visit.

Conditions

Treatment Resistant Depression; Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active rTMS treatment

3 sessions of active rTMS would be delivered to the left DMPFC daily, with 1800 pulse/session.

Group Type: EXPERIMENTAL

active rTMS treatment

Intervention Type: DEVICE

Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.

sham control

The identical treatment parameters will be administered akin to the active rTMS treatment, albeit devoid of actual stimulation.

Group Type: SHAM_COMPARATOR

sham rTMS treatment

Intervention Type: DEVICE

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.

Interventions

active rTMS treatment

Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.

Intervention Type: DEVICE

sham rTMS treatment

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• (1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and are not accompanied by psychiatric symptoms, with single or repeated episodes;
• (2) The Hamilton Depression Scale (HAMD) score for 17 items before randomization was ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score was ≥ 20 points;
• (3) Individuals aged ≥ 18 and ≤ 65 years old, regardless of gender;
• (4) Currently, at least one antidepressant has been used for 6 weeks and the dosage used cannot be lower than the prescribed range of drug use;
• (5) The Maudsley Staging Method (MSM) assesses patients as having at least moderate refractory levels (MSM score ≥ 7);
• (6) Before randomization, the current antidepressant treatment regimen should be stable for at least 4 weeks, and the dosage used should not be lower than the prescribed range of drug use;
• (7) Having received education for 5 years or more;
• (8) Understand the experiment and sign an informed consent form.

Exclusion Criteria

• (1) Meets the DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or depression caused by other medical issues;
• (2) Individuals with pacemakers, cochlear implants, or other metal foreign objects, as well as any electronic devices implanted in the body, contraindications for magnetic resonance imaging scans such as claustrophobia, and contraindications for rTMS treatment;
• (3) Concomitant history of epilepsy (with at least 2 non induced seizures with an interval of more than 24 hours, diagnosed with epilepsy syndrome, or having seizures within the past 12 months);
• (4) Individuals who have received modified electroconvulsive mECT, rTMS, or light therapy within 3 months;
• (5) Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
• (6) Complicated with serious heart, liver, kidney diseases, diabetes and other serious physical diseases;
• (7) Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
• (8) Have a history of drug and alcohol abuse within the past year;
• (9) First degree relatives suffer from bipolar disorder;
• (10) There is a significant risk of suicide (the 10th item of the MADRS scale is ≥ 5 points);
• (11) Difficulty in verbal communication to the point of being unable to communicate normally, understand or follow instructions, and unable to cooperate with treatment and evaluation;
• (12) Currently participating in clinical trials of other drugs or physical therapies (such as deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS);
• (13) The researchers believe it is not suitable to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changping Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesheng Liu, Ph.D.

Role: STUDY_CHAIR

Changping Laboratory

Locations

Hebei Mental Health Center

Hebei, Baoding, China

Site Status: RECRUITING

West China Hospital, Sichuan University

Chengdu, , China

Site Status: NOT_YET_RECRUITING

Inner Mongolia Mental Health Center

Hohhot, , China

Site Status: RECRUITING

Shandong Daizhuang Hospital

Jining, , China

Site Status: NOT_YET_RECRUITING

The Second Affiliated Hospital of Xinxiang Medical University

Xinxiang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Meiling Li, Ph.D.

Role: CONTACT

meilingli@cpl.ac.cn

010-80726688

Facility Contacts

Lili Zhang

Role: primary

Qiyong Gong

Role: primary

Dongsheng Lv

Role: primary

Zhonggang Wang

Role: primary

Yongfeng Yang

Role: primary

Other Identifiers

CPLTRDDM2024

Identifier Type: -

Identifier Source: org_study_id