pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD
Moderate Depression, Major Depressive Disorder, Severe Depression
About this trial
This is an interventional treatment trial for Moderate Depression focused on measuring transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation
Eligibility Criteria
Inclusion Criteria: Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes. Hospitalized patients aged 18-65 years (inclusive), male or female. Total HAMD-17 score ≥20 before randomization.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. Exclusion Criteria: Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on); 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; 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, and light therapy within 3 months; Patients 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; Patients with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure; The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding. Alcohol abuse or drugs abuse in the past 1 year; 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. Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation DBS, electroconvulsive therapy ECT, rTMS). Investigators think that was inappropriate to participate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Sham Comparator
Sham Comparator
active rTMS: 20min inter-session interval
active rTMS: 50min inter-session interval
sham rTMS: 20min inter-session interval
sham rTMS: 50min inter-session interval
Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.
Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.
Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.