pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression
NCT ID: NCT05948839
Last Updated: 2023-12-12
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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RECRUITING
NA
170 participants
INTERVENTIONAL
2023-07-11
2024-09-01
Brief Summary
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Detailed Description
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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 meet the eligibility requirements will be randomized in a double-blind manner in a 2:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a three- and nine-week follow-up visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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active rTMS treatment
3 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
active rTMS treatment
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.
sham control
3 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
sham rTMS treatment
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
Interventions
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active rTMS treatment
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.
sham rTMS treatment
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Hebei Mental Health Center
UNKNOWN
Shandong Daizhuang Hospital
UNKNOWN
West China Hospital
OTHER
The Second Affiliated Hospital of Xinxiang Medical University
UNKNOWN
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
Shandong Daizhuang Hospital
Jining, , China
The Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, , China
Countries
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Central Contacts
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Facility Contacts
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Bing Li
Role: primary
Zhonggang Wang
Role: primary
Yongfeng Yang
Role: primary
Other Identifiers
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CPLMDDDM150
Identifier Type: -
Identifier Source: org_study_id