Status:
UNKNOWN
pBFS Guided VS "5-cm Rule" rTMS Over DLPFC for MDD
Lead Sponsor:
Changping Laboratory
Conditions:
Major Depression
MDD
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS thera...
Detailed Description
After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who...
Eligibility Criteria
Inclusion
- 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.
- Inpatients or outpatients 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.
- Currently not taking any antidepressant medication. If previously medicated, a washout period of 7 days is required.
- 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;
- 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 plans to become pregnant during the trial and the 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.
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05964023
Start Date
August 20 2023
End Date
March 1 2025
Last Update
February 6 2024
Active Locations (4)
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1
Hebei Mental Health Center
Baoding, Hebei, China
2
Henan Mental Hospital
Xinxiang, Henan, China
3
Tianjin general hospital
Tianjin, Tianjin Municipality, China
4
Hangzhou Seventh People's Hospital
Hanzhou, Zhejiang, China