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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Individualized resting-state functional connectivity-guided iTBS
  • Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

National University Hospital, Singapore

Lead sponsor

National University of Singapore

Collaborator