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Translational Biomarkers in Accelerated Neuromodulation for Treatment-resistant Depression

RecruitingNAAges 18 Years - 65 YearsAllITAB - Institute for Advanced Biomedical Technolo…
NCT05798143 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: 30-50% of patients with Major Depressive Disorder (MDD) do not respond adequately despite two or more antidepressant treatments with proper dosage and timing of administration, configuring a condition of Treatment-Resistant Depression (TRD). Repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique that uses a magnetic field to stimulate focal cortical brain regions and it has been approved by the FDA for the treatment of TRD. Accelerated rTMS (arTMS) protocols involve multiple daily sessions of rTMS and they have been shown to be equally effective and safe compared to rTMS protocols, with reduced administration time and potentially faster antidepressant efficacy. Objectives: The main aim of this study is to identify MDD endophenotypes/biotypes predictive of response to accelerated treatment of rTMS to better characterize the clinical correlates of r

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📋 Eligibility rules (as published)
Inclusion Criteria: * Current diagnosis of Major Depressive Disorder (MDD), based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5); * Subjects without clinical response to at least two antidepressant treatments administered at adequate dosage and duration during the current episode; * Stable psychopharmacological treatment for at least one month. Exclusion Criteria: * Co-morbidity with organic diseases that could interfere with magnetic stimulation safety (epilepsy, brain lesions or diseases, previous neurosurgery, metal grafts, cardiac devices) based on applied procedure guidelines; * Diagnosis of Substance or Alcohol Use Disorder (DSM-5) in the past 6 months; * Substances of abuse or alcohol acute intoxication or abstinence; * Co-morbidity with significant organic or neurological diseases; * Personal or familiar (1st degree relatives) medical history of seizures; * Significant eye diseases that could interfere with ERG execution; * For female patients: Pregnancy/breastfeeding.
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What it tests

  • Accelerated Repetitive Transcranial Magnetic Stimulation
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Where

1 site
ITAB
Chieti, Italy
🤝 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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