Translational Biomarkers in Accelerated Neuromodulation for Treatment-resistant Depression

Launched by ITAB - INSTITUTE FOR ADVANCED BIOMEDICAL TECHNOLOGIES · Apr 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for people with Treatment-Resistant Depression (TRD), which affects 30-50% of those diagnosed with Major Depressive Disorder (MDD). Many patients do not find relief from their depression even after trying two or more antidepressant medications. The trial is testing a method called Accelerated Repetitive Transcranial Magnetic Stimulation (arTMS), which uses magnetic fields to stimulate specific areas of the brain. This approach involves multiple sessions in a short period, potentially leading to quicker improvements in mood.

To participate, individuals aged 18 to 65 who have not responded to at least two antidepressant treatments may be eligible. Participants will undergo a screening process, and if enrolled, they will receive arTMS treatment over five days, including several assessments like questionnaires, brain scans, and blood samples. After treatment, follow-up calls and a visit will help track their progress. This study aims to understand better which patients may respond best to this accelerated treatment, providing hope for those struggling with depression.

Gender

ALL

Eligibility criteria

• 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.