NCT07843875Toborzás még nem indult
Personalized Accelerated iTBS Versus Sham for Major Depressive Disorder
Personalized Functional-Connectivity-Targeted Accelerated Intermittent Theta-Burst Stimulation Versus Sham for Major Depressive Disorder
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 28.
Rövid összefoglaló (regiszter, angolul)
This randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). A total of 90 participants will be randomly assigned in a 1:1 ratio to receive either active iTBS or matched sham stimulation. Treatment will be administered over 5 consecutive days, with 10 stimulation sessions per day. For each participant, an individualized stimulation target within the left dorsolateral prefrontal cortex will be identified using resting-state functional magnetic resonance imaging (MRI). The primary objective is to compare the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34) between the active and sham groups. Changes in other clinical symptoms, treatment response, remission, and safety will also be assessed during follow-up through 8 weeks after treatment. Multimodal MRI, resting-state electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG) will be collected at prespecified time points. These measures will be used to explore treatment-related changes in brain function and connectivity and to identify potential neuroimaging and neurophysiological biomarkers associated with clinical improvement and the maintenance of treatment effects.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2026. júl. 12.
- Kezdés
- 2026. szept.
- Elsődleges befejezés
- 2027. okt.
- Fő szponzor
- Capital Medical University
- Betegségek
- Depresszió
- NCT-szám
- NCT07843875
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 90
- 2026. szept. és az elsődleges befejezés (2027. okt.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Current or previous diagnosis of bipolar disorder, a psychotic disorder, primary obsessive-compulsive disorder, post-traumatic stress disorder, or another psychiatric disorder considered incompatible with study participation.
- A response of "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the current depressive episode; suicidal behavior within the 6 months before screening; or current high suicide risk as determined by the investigator.
- Participation in another drug or medical-device clinical trial within 1 month before screening.
- Receipt of electroconvulsive therapy, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, deep brain stimulation, light therapy, or another systematic neuromodulation treatment within 1 month before screening.
Más betegség
- A skull defect or fracture, treatment-resistant epilepsy, brain tumor, stroke, or another serious medical or neurological condition that may affect study participation or safety.
- A cardiac pacemaker, cochlear implant, MRI-incompatible metallic foreign body, implanted electronic device, claustrophobia, or another contraindication to MRI or transcranial magnetic stimulation.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Egyéb
- A change of more than 20% in MADRS total score between screening and baseline.
- Pregnant or breastfeeding.
Kiket keres a vizsgálat
- Aged 22 to 65 years, regardless of sex. Right-handed.
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, confirmed using the Mini International Neuropsychiatric Interview (MINI), version 7.0.The current major depressive episode has lasted for at least 4 weeks.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 20 or greater at both screening and baseline.
- Stable depressive symptoms, defined as a difference in MADRS total score between screening and baseline of no more than 20%.
- Currently medication-free or receiving a stable dose of psychiatric medication for at least 4 weeks before enrollment, with agreement to maintain the same medication regimen through the Week 4 follow-up.
- Able to provide a complete and verifiable history of previous antidepressant treatments.
- Eligible to undergo magnetic resonance imaging (MRI).
- Able to complete all protocol-specified resting-state electroencephalography (EEG) and transcranial magnetic stimulation-electroencephalography (TMS-EEG) assessments.
- Able to understand and comply with the study procedures and provide written informed consent.
Életkor a regiszterben: 22 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.