RecruitingNot ApplicableNCT06350396

pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression

rTMS Intervention for DMPFC Treatment of Treatment-Resistant Depression Under the Guidance of Personalized Brain Functional Area Dissection (pBFS) Technology

Sponsor

Changping Laboratory

Enrollment

270 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder Treatment Resistant Depression

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

(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 Criteria13

(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.

Interventions

DEVICEactive 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.

DEVICEsham 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.