Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

MINDSET: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

This proposal seeks to carry out a prospective, single-arm open label study aimed at sustaining treatment-resistant depression (TRD) response in patients with TRD who had responded to prior individualized resting-state functional connectivity (rs-FC)-guided intermittent theta burst stimulation (iTBS). It also seeks to detect and predict relapse risk by integrating rs-FC iTBS with a TMS-adapted needs-based symptom-titrated algorithm based longitudinal ECT (STABLE) maintenance scheduling algorithm, and passive digital biomarkers.

Inclusion Criteria:

• Male/ female aged ≥ 21 to ≤ 70 years old
• Able to give informed consent
• Able to understand English
• DSM-V diagnosis of current/ past major depressive disorder (MDD) episode
• Non-response to an adequate trial (4 weeks) of at least 1 MDD medication as verified by a study clinician
• Ability to comply with passive wearable use and weekly mobile assessments
• Have previously completed a course of individualized, functional connectivity-guided accelerated iTBS and shown a clinical response (as defined by a ≥50% improvement in MADRS score against baseline, any time within 3 months following an acute iTBS course)
• Able to comply with the full 12-month protocol inclusive of continuous digital monitoring

Exclusion Criteria:

• DSM-5 psychotic disorder
• Drug or alcohol abuse or dependence (preceding 3 months)
• Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
• Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
• Tattoos containing ferromagnetic ink or permanent piercings
• Pregnancy
• Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)
• Participant does not have the capacity to provide consent