NCT06166082Befejeződött
Intensive Accelerated iTBS for the Treatment-Resistant Depression
Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 11.
Rövid összefoglaló (regiszter, angolul)
This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 130 (tényleges)
- Első benyújtás
- 2023. dec. 3.
- Kezdés
- 2023. dec. 22.
- Elsődleges befejezés
- 2025. márc. 21.
- Fő szponzor
- Changping Laboratory
- Betegségek
- Depresszió
- NCT-szám
- NCT06166082
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 130
- 2023. dec. 22. és az elsődleges befejezés (2025. márc. 21.) között
- 5 helyszín, 1 országban
- 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
- Individuals with pacemakers, cochlear implants, or other metal objects, as well as any electronic devices implanted in the body, and those with claustrophobia Contraindications for magnetic resonance imaging scans such as fear, and contraindications for 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 Syndromes, or seizures within the past 12 months;
- Received TMS treatment before participating in the trial;
- Individuals who have received ECT or phototherapy within three months;
- Previously received antidepressant treatment with implanted devices (such as DBS, VNS);
- Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
- Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past year;
- Current in clinical trials of other drugs or physical therapies (DBS, ECT, rTMS);
Más betegség
- Meets DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, and psychiatric disorders Developmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or other medical problems;
- Complicated with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, which cause abnormal symptoms and signs of brain nerves, Or physical exhaustion;
- First-degree relatives suffer from bipolar disorder;
Életkor
- Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
Egyéb
- No response to ECT treatment (>8 times);
- High risk of suicide;
- Difficulty in communication to understand or follow instructions, and unable to cooperate with treatment and evaluation;
- The researchers believe it is not suitable to participate.
Kiket keres a vizsgálat
- 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;
- Hamilton Depression Scale (HAMD-17) scores for 17 items ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score is ≥ 20 points;
- hospitalized/outpatient patients aged ≥ 22 and ≤ 65 years old, male or female;
- The Maudsley Staging Method (MSM) assesses patients as at least moderate refractory (MSM score ≥ 7 points);
- Stable use of antidepressants for 4 weeks before randomization, with the type of antidepressant used being selective serotonin reuptake Selective serotonin reuptake inhibitors (SSRIs) or/and serotonin and norepinephrine reuptake Serotonin-norepinephrine reuptake inhibitors (SNRIs), the therapeutic dose is within the dosage range as the drug manual recommended;
- Understand the trial and sign the informed consent form.
Életkor a regiszterben: 22 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hebei Mental Health Center | Baoding | Kína | Ismeretlen állapot |
| HuiLongGuan Hospital | Beijing | Kína | Ismeretlen állapot |
| Wuhan Mental Health Center | Wuhan | Kína | Ismeretlen állapot |
| Xianyue Hospital | Xiamen | Kína | Ismeretlen állapot |
| Zhumadian Second People's Hospital | Zhumadian | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.