pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

Launched by CHANGPING LABORATORY · Jul 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people suffering from treatment-resistant depression, which means their current medications haven't helped improve their symptoms. The treatment being tested is called pBFS-guided rTMS, a type of therapy that uses magnetic stimulation to target a specific part of the brain known as the dorsomedial prefrontal cortex (DMPFC). The researchers want to find out if this therapy is safe and effective for patients who have not responded well to traditional antidepressant medications.

To participate in this trial, individuals must be between 18 and 65 years old and have been diagnosed with depression that meets specific criteria. They should have tried at least one antidepressant without success and currently be on a stable medication regimen. Participants will be monitored closely throughout the study, and they’ll need to agree to follow the treatment plan and attend scheduled visits. It’s important to note that certain individuals, such as those with serious medical conditions, a history of seizures, or who are currently receiving other mental health therapies, may not be eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
• • 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 ≥25 before randomization.
• • 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.
• • Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
• Exclusion Criteria:
• • 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;
• • Female of childbearing potential who plans to become pregnant during the trial.
• • Female 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.
• • 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.
• • Investigators think that was inappropriate to participate.