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rTMS Response Trajectories in Depression

RecruitingNAAges 18 Years - 64 YearsAllChinese University of Hong Kong
NCT03348761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Notwithstanding the cumulative evidence on the safety and efficacy of transcranial magnetic stimulation in depression care, the non-response rate to transcranial magnetic stimulation (TMS) amongst treatment-resistant depression has remained substantial despite the health care cost and time incurred. There remains a compelling clinical need to find valid biomarkers to inform personalized treatment. Using supervised machine learning on 4 combined features of neuroimaging markers, our group recently reported excellent prediction for clinical response in 70 patients receiving TMS to left dorsolateral prefrontal cortex for medication-resistant major depression in 2015-18 (Phase 1 study).The clinical utility of these potential neuroimaging biomarkers is still uncertain without further validation of the trained model in an independent clinical cohort.

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📋 Eligibility rules (as published)
Inclusion Criteria: * right-handed * meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder * at least moderate episode or with a score of \>20 on Montgomery-asberg Depression Rating Scale (MADRS) and \>18 on Hamilton Depression Rating Scale(HDRS) 17-item; * has failed to respond adequately to at least one full course (\>6 weeks) of antidepressant medication or medication intolerant. Exclusion Criteria: * significant head trauma * active abuse of alcohol or illegal substances * current psychotic symptoms * suicide ideation/recent suicide attempts * other DSM-IV Axis I and II psychiatric diagnosis * neurological disorders and contraindications to fMRI (e.g. pace makers, metal implants, pregnancy) or rTMS, or having undergone electroconvulsive therapy in the preceding year.
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What it tests

  • rTMS group
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Where

1 site
Department of Psychiatry, CUHK
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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