Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2023-08-20
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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pBFS rTMS
3 sessions of active rTMS would be delivered to the pBFS-guided left DLPFC daily, with a session of 1800 pulse.
pBFS rTMS
Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
5-cm rTMS
3 sessions of active rTMS would be delivered to the "5-cm rule" guided left DLPFC daily, with a session of 1800 pulse.
5-cm rTMS
Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by "5-cm rule".
Interventions
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pBFS rTMS
Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
5-cm rTMS
Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by "5-cm rule".
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Changping Laboratory
OTHER
Responsible Party
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Principal Investigators
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Hesheng Liu, Ph.D.
Role: STUDY_CHAIR
Changping Laboratory
Locations
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Hebei Mental Health Center
Baoding, Hebei, China
Henan Mental Hospital
Xinxiang, Henan, China
Tianjin general hospital
Tianjin, Tianjin Municipality, China
Hangzhou Seventh People's Hospital
Hanzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Bing Li
Role: primary
Yongfeng Yang, M.D
Role: primary
chunshui yu
Role: primary
Wei Deng
Role: primary
Other Identifiers
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CPLMDDDLV5cm
Identifier Type: -
Identifier Source: org_study_id
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