Status:
UNKNOWN
pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder
Lead Sponsor:
Changping Laboratory
Conditions:
Depression
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators aim to evaluate the safety and efficacy of pBFS-guided DMPFC target and high-dose rTMS therapy for the treatment of patients with treatment-resistant depression
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treat...
Eligibility Criteria
Inclusion
- DSM-5 diagnosis of depressive disorder, recurrent episodes;
- A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale;
- Aged 18-65 years, female or male;
- Inadequate response to at least one antidepressant trial of adequate doses and duration;
- The MSM (Maudsley Staging Method) score ≥ 7;
- Stable antidepressant regimen for at least 4 weeks before treatment;
- Understand the trial and sign the informed consent.
Exclusion
- 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;
- 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;
- The female of childbearing potential who plans to become pregnant during the trial, and that is pregnant or breastfeeding.
- Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
- First-degree relatives have bipolar affective disorder.
- Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
- Investigators think that was inappropriate to participate.
Key Trial Info
Start Date :
July 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05964036
Start Date
July 21 2023
End Date
July 20 2024
Last Update
February 7 2024
Active Locations (1)
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1
Hebei Mental Health Center
Baoding, Hebei, China