Status:
UNKNOWN
pBFS-Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression
Lead Sponsor:
Changping Laboratory
Conditions:
Major Depressive Disorder
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive d...
Detailed Description
Stimulation of the dorsolateral prefrontal cortex(DLPFC) and ventromedial prefrontal cortex (DMPFC) as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy. H...
Eligibility Criteria
Inclusion
- 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 ≥20 before randomization.
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- 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.
- The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
- 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
- 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;
- 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 serious heart, liver, kidney diseases, diabetes and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
- 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;
- Female of childbearing potential who plans to become pregnant during the trial.
- Female that is pregnant or breastfeeding.
- Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) 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.
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05976009
Start Date
August 29 2023
End Date
September 20 2024
Last Update
February 7 2024
Active Locations (1)
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1
Xianyue Hospital
Xiamen, China