NCT03986658Visszavonva
Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Treatment Durations From Ten Days to One Day
Dose-Response Study of Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 2.
Megadott ok: Due to a strategic decision by the sponsor, the study has been relocated to a different site, necessitating the withdrawal of this specific registration.
Rövid összefoglaló (regiszter, angolul)
This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. In contrast, the First Dawn rTMS system by NeuroQore can sustain a repetitive linear asymmetric pulse. In addition, identification of rTMS treatment sites in adolescents with TRD most often relies on anatomic landmarks, but the First Dawn rTMS system utilizes personal fMRI data in a novel algorithm to determine where to apply the rTMS in each patient. Based on adult data in healthy volunteers and patients with TRD, the investigators propose that the First Dawn rTMS system will be acceptable and well-tolerated by adolescents and will have minimal side effects. Please see https://clinicaltrials.gov/ct2/show/NCT02667041 for details on the completed pilot study in adults. The investigators aim to investigate acceptability, tolerability, and side effects in groups of patients receiving treatment in numbers of sessions/day that are gradually accelerated over the course of the study. Results will be used to inform the development of a randomized controlled trial.
- Állapot (regiszter)
- Visszavonva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2019. máj. 31.
- Kezdés
- 2025. máj.
- Elsődleges befejezés
- 2028. okt.
- Fő szponzor
- NeuroQore Inc.
- Betegségek
- Depresszió
- NCT-szám
- NCT03986658
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A regiszterben nem jelölt feltételek
- Inclusion:
- Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
- Meets criteria for TRD:
- failed two adequate courses of antidepressant medication OR
- failed adequate course of medication AND one course of psychotherapy.
- Score of > 40 on Child Depression Rating Scale-Revised OR score of > 20 on Child Depression Inventory-2.
- Fluent in speaking and reading English.
- Exclusion:
- Positive pregnancy test.
- Current or past: bipolar disorder, psychotic disorder, autism spectrum disorder, intellectual disability, substance use disorder, conduct disorder, as determined by a structured psychiatric interview.
- Medical illness that could lower the seizure threshold, e.g., epilepsy from any cause.
- Medications that could lower the seizure threshold or affect brain function.
- Psychotropic medications changed in two weeks prior to enrollment.
- Fails the TMS safety screening questionnaire.
- Fails fMRI screening process.
- Left-handed (may indicate different cortical lateralization which could affect outcomes).
- Involuntarily committed to the hospital.
Életkor a regiszterben: 15 év – 17 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Children'S Hospital Of Eastern Ontario | Ottawa | Kanada | Ismeretlen állapot |
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