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

Plain Language Summary

Simplified for easier understanding

This study tests a type of non-invasive brain stimulation called rTMS (repetitive transcranial magnetic stimulation) guided by brain wave patterns to treat people with depression that has not responded to antidepressant medications (treatment-resistant depression). **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with major depression (single or recurrent episode, without psychotic features) - You have tried at least one antidepressant at an adequate dose for at least 6 weeks without sufficient improvement - Your depression scores are high on standard rating scales (HAMD-17 ≥20 and MADRS ≥20) - Your depression is classified as at least moderately treatment-resistant **You may NOT be eligible if...** - You have a history of epilepsy or seizures - You have a metal implant in your skull or a pacemaker (which makes rTMS unsafe) - You have bipolar disorder or a psychotic condition - You are pregnant or breastfeeding - You are acutely suicidal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.