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

Not Yet RecruitingNA

Sponsor: National University Hospital, Singapore

Conditions: Depression Disorder

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

Countries: Singapore

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 overview

Sex: ALL

Age: 21 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Singapore, Singapore