Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder : An Open Trial of Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
Study Description:This is a safety and pilot efficacy study of open, neuronavigated intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS) in medication-free youth with treatment-resistant major depression. The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents.Objectives:The study has two objectives: 1) To evaluate safety, feasibility, and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression; 2) To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression.Endpoints:Primary Endpoints:Children s Depression Rating Scale (CDRS); rates of treatment completion and adverse events on standard rating scalesSecondary Endpoints:Clinical Global Impression Improvement Scale (CGI-I)Mood and Feelings Questionnaire (MFQ)Screen for Child Anxiety Related Disorders (SCARED)Resting state fMRI correlations across brain regionsTask-based fMRI activation to cognitive conflictFractional anisotropy on diffusion tensor imagingNeurochemicals assessed by magnetic resonance spectroscopy.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 02. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: December 15, 2022, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| Study ID: |
NCT05652465 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000012122 |
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| 245 | 1 | 0 | |a Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder |b An Open Trial of Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder |
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| 520 | |a Study Description:This is a safety and pilot efficacy study of open, neuronavigated intermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS) in medication-free youth with treatment-resistant major depression. The hypothesis is that intermittent theta burst TMS is a safe and potentially effective treatment for treatment-resistant major depression in adolescents.Objectives:The study has two objectives: 1) To evaluate safety, feasibility, and potential efficacy of iTBS in medication-free youth with the goal of supporting a future randomized controlled trial in youth with treatment-resistant major depression; 2) To assess changes in levels of psychiatric symptoms and brain imaging parameters after iTBS in youth with treatment-resistant major depression.Endpoints:Primary Endpoints:Children s Depression Rating Scale (CDRS); rates of treatment completion and adverse events on standard rating scalesSecondary Endpoints:Clinical Global Impression Improvement Scale (CGI-I)Mood and Feelings Questionnaire (MFQ)Screen for Child Anxiety Related Disorders (SCARED)Resting state fMRI correlations across brain regionsTask-based fMRI activation to cognitive conflictFractional anisotropy on diffusion tensor imagingNeurochemicals assessed by magnetic resonance spectroscopy | ||
| 650 | 2 | |a Depressive Disorder | |
| 650 | 2 | |a Depression | |
| 650 | 2 | |a Depressive Disorder, Major | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
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